FDA.reportPublic FDA data

WOODSLEEP Tallow Sunscreen

Product NDC
85053-003
11-digit product format
850530003
Labeler code
85053
Product ID
85053-003_448be66c-8d15-e97b-e063-6394a90a4334
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Shantou Woodsleep Biotechnology Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-28
Substance
TALLOW
Active strength
.012 mg/60mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
WOODSLEEP Tallow Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TALLOW.012 mg/60mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98HPY76U4WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33cdde09-e7ee-e003-e063-6394a90a8762Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85053-003-01WOODSLEEP Tallow Sunscreen60 mg in 1 BOXCREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85053-003WOODSLEEP TALLOW SUNSCREEN (TITANIUM DIOXIDE) CREAM [SHANTOU WOODSLEEP BIOTECHNOLOGY CO., LTD.]1Current NDC, 1 package rows20250429_33cdde09-e7ee-e003-e063-6394a90a8762.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 92 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f4599b-de62-2bc7-e063-6394a90a69ab2025-12-31WarningsExact identifier
application number: M020
Hawaiian Tropic Everyday Active SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc8e2ee8-e67f-ef5d-e053-2995a90a15202025-12-31WarningsExact identifier
application number: M020
Sunscreen Glowing, SPF 30SUNSCREEN GLOWING LOTIONCardinal Health, Inc28ed3b60-1139-f657-e063-6394a90a52fa2025-12-31WarningsExact identifier
application number: M020
Sunscreen Setting Spritz, SPF 45SUNSCREEN SETTING SPRAYCardinal Health, inc.293e9656-8644-b9aa-e063-6294a90a5b272025-12-31WarningsExact identifier
application number: M020
Sunscreen Setting Spritz, SPF 45SUNSCREEN SETTING SPRAYFSA Store Inc473d6804-8d20-6899-e063-6294a90a31312025-12-31WarningsExact identifier
application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47428cd4-fbad-ba7a-e063-6394a90a1c5c2025-12-31WarningsExact identifier
application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47433a62-91e0-b031-e063-6294a90a0d492025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4743b6a9-4d79-1b2b-e063-6394a90a97102025-12-31WarningsExact identifier
application number: M020
Royal Jelly Radiance Foundation Broad Spectrum SPF 20 EarthOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.0edc7bd4-9350-48e1-bbfe-e6450458ae592025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - BronzeOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.90fbf555-106c-4131-b572-ead9bbb246e62025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - HoneyOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.1accbe67-c722-4af7-8422-0559ac4a987a2025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - BareOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5c0805c7-9b92-4c08-877c-64e7203084302025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20- NaturalOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.0cc5429d-ace4-4060-b993-1b607218eaf82025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20-NudeOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.b1851c5d-32ad-482a-bd24-2f280a68ef9e2025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 -SpiceOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.6164dc23-81c2-48b8-b309-2c5a81fe13a42025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4744e501-f12a-6d25-e063-6394a90a25742025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - TawnyOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.d7c4e758-3af2-40c6-bbe1-37e6fd0a5eb62025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - CappuccinoOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.30601a73-089e-4fa7-8fb7-6b108498934a2025-12-31WarningsExact identifier
application number: M020
Good Karma Dry Oil Mineral Sunscreen SPF-30ZINC OXIDE SUNSCREENSOLARA SUNCARE, INC.209c4913-29e6-24ca-e063-6294a90a68722025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47456bf5-9f6c-e6a5-e063-6294a90a70542025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85053-003-018505300030160 mg in 1 BOX (85053-003-01) 60 mg2025-04-28NoNoCurrent