DrugDashboards

WOODSLEEP Sunscreen Balm

Titanium Dioxide · ARTEMISIA ARGYI LEAF .012 mg/60mg · Cream · Topical · Shantou Woodsleep Biotechnology Co., Ltd.

NDC 85053-0004-01 · 60 mg in 1 BOTTLE, GLASS · OTC MONOGRAPH DRUG · View full market →

The short version

35 companies list this market — deep enough that no single failure threatens the supply.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

ⓘ How this was built
Data sources
  • FDA NDC Directory (openFDA) — labelers active in the last 30 days, repackagers classified from DailyMed SPL establishment roles
  • CMS NADAC — latest price vs the price in effect ~12 months earlier
  • FDA drug shortages and enforcement reports (openFDA)
  • FDA inspection classifications; DrugDashboards fragility score and 90-day shortage model
Method

Each sentence is a template that fires only when its condition holds in the data shown lower on this page: maker counts are distinct FDA labelers listing this molecule and dosage form in the last 30 days minus classified repackagers; the price trend compares the newest NADAC with the last price in effect at least 9 months earlier; shortage and recall sentences restate FDA rows for this drug's presentations (Class I/II, trailing 12 months); the plant sentence needs a MANUFACTURE-role establishment with a drug-quality OAI in 24 months; the verdict restates the fragility band; the risk sentence appears only when the model's probability is at least 1.5× the typical market. Nothing here is inferred beyond those rules.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Medicare Part D

Medicare Part D does not cover over-the-counter drugs — by law it pays only for products requiring a prescription.

How Part D pricing works →

NADAC price per unit

ⓘ How this was built
Data sources
  • CMS NADAC weekly files (data.medicaid.gov), December 2024 onward
  • CMS NADAC per-year archive files, 2013 – November 2024, averaged per month
  • CMS Federal Upper Limit file — weighted average manufacturer price (WAMP) of the generic group (dashed line)
Method

One line, two regimes: before December 2024 each point is the average of that month's archived NADAC rows for this NDC; from December 2024 each point is a row from the weekly file, which CMS publishes only when the price changes, so the line holds flat until the next change and is extended to today when the last row is under 6 months old. Since the December 2024 file CMS computes generic NADAC as a 3-month moving average, so recent generic moves are smoothed and lag the market. The dashed WAMP is the manufacturer-side average for the whole multiple-source group, not this NDC alone. To check a point: open the NADAC file for that date on data.medicaid.gov and find this NDC.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NDCs that have a NADAC price and a generic name.

Regulatory

Application
M020
TE code
—
Approval date
—
Patents / exclusivity
None on file
ⓘ How this was built
Data sources
  • FDA Orange Book data files — patent and exclusivity tables for application M020, edition retrieved 2026-08-24
Method

Rows are the Orange Book's patent and exclusivity listings for this NDA, de-duplicated across product numbers (the file repeats a listing for every strength). A listed patent is a claim the sponsor filed; it may cover a use rather than the molecule, may be challenged, and may be delisted — a listing is not proof a generic is blocked. Pediatric extensions appear as *PED rows. FDA blocks automated downloads of the Orange Book from cloud servers, so the edition can trail FDA's monthly release; the retrieval date above is the edition shown. To check: search the application number on FDA's Orange Book site.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Shortage history

ⓘ How this was built
Data sources
  • FDA drug shortages via openFDA (current file: Current, To Be Discontinued, and recently Resolved rows)
  • Internet Archive (Wayback) snapshots of FDA's shortage list since 2019, reconstructed into episodes
  • DrugDashboards Kaplan–Meier duration curves and conditional duration model
Method

Top rows are FDA's live listings whose package NDC is this product or another package of the same generic name and dosage form. openFDA drops resolved rows after about six months, so older episodes come from monthly Wayback snapshots of FDA's file, matched on the molecule with dosage-form words stripped (that matching can pull in other salts or forms of the same molecule — the presentation is shown so you can tell). 'Month N of a typical M' compares this episode's age with the Kaplan–Meier median for its form class (injectable, oral solid, other) over episodes since October 2019, open episodes censored; the resolution odds come from a model conditioned on the episode's age and reason. To check: FDA's drug shortage database, and web.archive.org for its history.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

No FDA shortage listing for this drug's presentations in the current file, and no archived episode since 2019.

Recalls (this NDC)

ⓘ How this was built
Data sources
  • FDA drug enforcement reports via openFDA
Method

Enforcement reports whose product NDC list includes this exact package NDC, newest first, with FDA's classification (I = reasonable probability of serious harm, II = temporary or reversible harm, III = unlikely to cause harm) and the recall's current status. Reports for other packages of the same drug are not shown here; 275 of the last year's Class I/II reports carry no NDC at all and cannot be matched. To check: search the recall number on openFDA or FDA's enforcement reports.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

No enforcement reports list this package NDC.

Labelers of Titanium Dioxide (Cream)

35 labelers active in the last 30 days; 0not seen for 30+ days. Keyed on FDA's generic-name string — other salts or forms of the molecule are separate rosters.

ⓘ How this was built
Data sources
  • FDA NDC Directory (openFDA), read daily since 2026-07-15 — labeler_name per package
  • DailyMed SPL establishment roles + name patterns → derived.labeler_kinds (repackager / manufacturer / unknown)
Method

One row per labeler that lists any package with this exact generic-name string and dosage form; strengths are combined. 'First seen' is the first daily snapshot that contained the labeler here (2026-07-15 for everything present at the start), 'last seen' the most recent; a labeler counts as active when seen in the last 30 days. Repackagers and relabelers are flagged when their own labels show only repack/relabel operations or their name matches a known repackager, and are excluded from every 'makers' count on this page. Listing is not volume: a labeler with a listed NDC may ship little or nothing. To check: search the generic name in FDA's NDC Directory and list the labelers.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

LabelerStrengthsFirst seenLast seen
3LAB, Inc.TITANIUM DIOXIDE 78.6 mg/mLJul 15, 2026Sep 3, 2026
Amway CorpTITANIUM DIOXIDE 40.25 mg/mLJul 15, 2026Sep 3, 2026
Chantecaille Beaute IncTITANIUM DIOXIDE 96.075 mg/gJul 15, 2026Sep 3, 2026
Chipican LLCTITANIUM DIOXIDE 10.4 g/100gJul 15, 2026Sep 3, 2026
Farmasi US LLCTITANIUM DIOXIDE 35 mg/mL; TITANIUM DIOXIDE 40 mg/mLJul 15, 2026Sep 3, 2026
Inel Cosmetics Co., Ltd.TITANIUM DIOXIDE 65.1 mg/mLJul 15, 2026Sep 3, 2026
Kenvue Brands LLCTITANIUM DIOXIDE 36 mg/mLJul 15, 2026Sep 3, 2026
Orveon Global US LLCTITANIUM DIOXIDE .1 g/2gJul 15, 2026Sep 3, 2026
Shantou Ouhoe Technology Co., Ltd.CENTELLA ASIATICA .01 mg/50mg; BEESWAX .016 mg/80mg; BUTYROSPERMUM PARKII (SHEA) BUTTER .016 mg/80mg; OLEA EUROPAEA (OLIVE) FRUIT OIL .016 mg/80mg; PROPOLIS WAX .016 mg/80mg; SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL .016 mg/80mg; CENTELLA ASIATICA .012 mg/60mg (+6 more)Jul 15, 2026Sep 3, 2026
Shiseido Americas CorporationTITANIUM DIOXIDE 2.73735 g/35mLJul 15, 2026Sep 3, 2026
Tan Alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret Anonim SirketiTITANIUM DIOXIDE 35 mg/mL; TITANIUM DIOXIDE 40 mg/mLJul 15, 2026Sep 3, 2026
THG Beauty USA LLCTITANIUM DIOXIDE 4.2 g/100mLJul 15, 2026Sep 3, 2026
3LAB, IncTITANIUM DIOXIDE 121.6 mg/mL; TITANIUM DIOXIDE 77.2 mg/mLJul 15, 2026Sep 2, 2026
Baxter of CaliforniaTITANIUM DIOXIDE 30 mg/gJul 15, 2026Sep 2, 2026
Baxter of California, LLCTITANIUM DIOXIDE 30 mg/gJul 15, 2026Sep 2, 2026
Boscia LLCTITANIUM DIOXIDE 6.4 g/100g; TITANIUM DIOXIDE 6.45 g/100gJul 15, 2026Sep 2, 2026
Estee Lauder IncTITANIUM DIOXIDE 14 mg/mLJul 15, 2026Sep 2, 2026
Guangdong Aimu Biological Technology Co., LtdASCORBIC ACID 3 g/100g; TITANIUM DIOXIDE 6 g/100g; ZINC OXIDE 6 g/100g; ASCORBIC ACID 6 g/100g; TITANIUM DIOXIDE 6 g/100g; ZINC OXIDE 3 g/100gJul 15, 2026Sep 2, 2026
Guthy-Renker LLCTITANIUM DIOXIDE 4 mg/100mLJul 15, 2026Sep 2, 2026
HANCHOYEANBIOTEC Co.,Ltd.ALOE BARBADENSIS LEAF POWDER .01 mg/50mg; ORYZA SATIVA (RICE) SEED OIL .01 mg/50mg; ARTEMISIA VULGARIS ROOT .0036 mg/18mg; CAMELLIA JAPONICA FLOWER .0036 mg/18mg; BETULA ALBA JUICE .01 mg/50mg (+1 more)Jul 15, 2026Sep 2, 2026
Hey Honey Inc.TITANIUM DIOXIDE 13.5 g/100mLJul 15, 2026Sep 2, 2026
L'Oreal USA Products IncTITANIUM DIOXIDE 11.5 mg/mLJul 15, 2026Sep 2, 2026
Merle Norman Cosmetics, IncTITANIUM DIOXIDE 2.4 g/30gJul 15, 2026Sep 2, 2026
Naturally Uncommon, LLCTITANIUM DIOXIDE 8.8 g/100mLJul 15, 2026Sep 2, 2026
Noxell CorporationTITANIUM DIOXIDE 4.9 mg/.1g; TITANIUM DIOXIDE 9 g/100gJul 15, 2026Sep 2, 2026
Perbelle Cosmetics Global Ltd.TITANIUM DIOXIDE 120 mg/gJul 15, 2026Sep 2, 2026
Rodan & FieldsTITANIUM DIOXIDE 20 mg/mL; ZINC OXIDE 120 mg/mLJul 15, 2026Sep 2, 2026
S.a. Comptoir Nouveau De La ParfumerieTITANIUM DIOXIDE 73 mg/mLJul 15, 2026Sep 2, 2026
Sandra Plasencia SkincareTITANIUM DIOXIDE 1 g/100mLJul 15, 2026Sep 2, 2026
Shaklee CorporationTITANIUM DIOXIDE 42 mg/mLJul 15, 2026Sep 2, 2026
Shantou Eelhoe Daily Chemical Technology Co., Ltd.ALOE BARBADENSIS LEAF .005 mg/50mg; ARTEMISIA VULGARIS ROOT .0036 mg/18mg; CAMELLIA JAPONICA FLOWER .054 mg/18mg; CENTELLA ASIATICA .004 mg/20mg (+5 more)Jul 15, 2026Sep 2, 2026
Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.2000 MW) .008 mg/40mg; HYDROLYZED RICE PROTEIN (ENZYMATIC .008 mg/40mg; LIMOSILACTOBACILLUS FERMENTUM; ARTEMISIA ARGYI LEAF .0036 mg/18mg; CAMELLIA JAPONICA SEED OIL .0036 mg/18mg; ARTEMISIA VULGARIS OIL .036 mg/18mg; CAMELLIA JAPONICA FLOWER OIL .036 mg/18mg (+4 more)Jul 15, 2026Sep 2, 2026
Shantou Woodsleep Biotechnology Co., Ltd.ARTEMISIA ARGYI LEAF .012 mg/60mg; AVOBENZONE .75 mg/50mg; OCTOCRYLENE 1 mg/50mg; PHENYLBENZIMIDAZOLE SULFONIC ACID 1 mg/50mg; TITANIUM DIOXIDE 4.5 mg/50mg; TALLOW .0114 mg/57mg (+2 more)Jul 15, 2026Sep 2, 2026
Coral Reef Park Co., Inc.TITANIUM DIOXIDE 80 mg/mLJul 15, 2026Aug 28, 2026
LG Household and Healthcare, Inc.TITANIUM DIOXIDE 121.6 mg/gJul 15, 2026Aug 28, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 15, 2026.

Cite this page

DrugDashboards, "WOODSLEEP Sunscreen Balm — NDC 85053-0004-01," retrieved September 4, 2026, https://drugdashboards.com/drug/85053000401.

Free to cite with attribution — see how the data is put together.