FDA.reportPublic FDA data

Tinted Mineral Sunscreen

Product NDC
85513-203
11-digit product format
855130203
Labeler code
85513
Product ID
85513-203_458a10b1-70d3-5984-e063-6294a90a6c8b
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
THE AESTHETICS ACADEMY, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-22
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; mg/g
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
Tinted Mineral Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
364b9560-f7a1-ed8f-e063-6294a90a2c41Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85513-203-50Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

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 166 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naturium UV Reflect Antioxidant SPF 50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc0a5c6fc8-6cdc-0ae5-e063-6394a90ae01c2025-11-14WarningsExact identifier
application number: M020
CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc372894af-bed7-474f-95d4-69a8c3f215ef2025-11-14WarningsExact identifier
application number: M020
HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEONEAND CO., LTD.2dc41560-f4a7-5f0b-e063-6294a90a06302025-11-13WarningsExact identifier
application number: M020
Covey Sun and Done Daily MoisturizingZINC OXIDECovey Skinfbcf8204-0673-99aa-e053-6294a90ac26e2025-11-13WarningsExact identifier
application number: M020
SOL Science The FiftyZINC OXIDEBeauty Pie01548858-8b0e-494a-e063-6294a90a8e992025-11-13WarningsExact identifier
application number: M020
Balmere Mineral Sunscreen Moisturizer PrimerZINC OXIDEBalmere00d813e0-eb97-a6ba-e063-6394a90aa5252025-11-13WarningsExact identifier
application number: M020
Dove Clinical Care96H PROTECTION FRESH PEACH DRY SPRAY ANTIPERSPIRANT DEODORANTConopco d/b/a Unilever437eb2a8-428c-8339-e063-6394a90a74b22025-11-13WarningsExact identifier
application number: M020
Dove Clinical Care96H PROTECTION ORIGINAL CLEAN DRY SPRAY ANTIPERSPIRANT DEODORANTConopco d/b/a Unilever437f4db5-552f-1550-e063-6394a90aaedb2025-11-13WarningsExact identifier
application number: M020
Depology Essential Mineral UV CareZINC OXIDEDepology Holdings LLC1d48cdee-be67-14c0-e063-6294a90a74222025-11-13WarningsExact identifier
application number: M020
Hanalei Face MoisturizingZINC OXIDEHanalei Beauty Company LLC1f7c1a68-5aea-0deb-e063-6394a90a3a432025-11-13WarningsExact identifier
application number: M020
Glo SkinTITANIUM DIOXIDE, ZINC OXIDEGlo Skin Beautyf4bed574-68c1-0d2c-e053-2a95a90a15ff2025-11-13WarningsExact identifier
application number: M020
Dove Clinical Care96H PROTECTION SOFT SENSITIVE DRY SPRAY ANTIPERSPIRANT DEODORANTConopco d/b/a Unilever4380036a-7698-03e7-e063-6294a90a73012025-11-13WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL AIR FIT SUNSCREENSUNSCREENTPERENNEBELLfe2148db-9020-9343-e053-6294a90adf702025-11-13WarningsExact identifier
application number: M020
skin MDOCTINOXATE, OCTISALATE, HOMOSALATE21st Century Formulationse809e1d3-0a6d-730d-e053-2a95a90aedb92025-11-13WarningsExact identifier
application number: M020
Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCa64045dd-8f70-43f1-be6f-ad1556c0e2102025-11-13WarningsExact identifier
application number: M020
Florida Glow SPF 50AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATESoutheast Holdings Corp.dcb43ee0-5ab0-495a-8e68-90cab881337d2025-11-12WarningsExact identifier
application number: M020
Florida Glow SPF 30AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATESoutheast Holdings Corp.20538bc0-10c3-492c-952a-6797e46003f22025-11-12WarningsExact identifier
application number: M020
Florida Glow SPF 15AVOBENZONE,OCTOCRYLENE,OCTISALATESoutheast Holdings Corp.56af704a-bda9-49ed-a177-a8480d90458b2025-11-12WarningsExact identifier
application number: M020
Florida Glow face shield SPF 55HOMOSALATE, OCTOCRYLENE, ZINC OXIDESoutheast Holdings Corp.cea54600-5308-4b9f-98ca-fef0b26d79c12025-11-12WarningsExact identifier
application number: M020
Florida Glow SPF 30ZINC OXIDESoutheast Holdings Corp.4bf1ca6b-5d87-40ee-97f4-89f1bfadcecb2025-11-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85513-203-508551302035053 g in 1 BOTTLE, PUMP (85513-203-50) 53 g2023-12-22NoNoCurrent