FDA.reportPublic FDA data

Tinted Mineral Sunscreen

Product NDC
85585-203
11-digit product format
855850203
Labeler code
85585
Product ID
85585-203_46161253-7b9f-afb1-e063-6394a90a64d5
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-30
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
38; 80 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
ZINC OXIDE38 mg/g
TITANIUM DIOXIDE80 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
36c0400b-8ad9-654b-e063-6294a90ad040Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85585-203-15Tinted Mineral Sunscreen1.5 g in 1 PACKETCREAM1.52
85585-203-50Tinted 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 181 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pavise Lip Defense tinted hydrating oil (hue 604)ZINC OXIDEB.A.I. Biosciences INC.f4ebbc1d-d521-1a47-e053-2a95a90a6f842025-10-09WarningsExact identifier
application number: M020
pavise Lip Defense tinted hydrating oil (hue 774)ZINC OXIDEB.A.I. Biosciences INC.f4ebd850-11a8-0d43-e053-2a95a90a2d342025-10-09WarningsExact identifier
application number: M020
pavise Lip Defense tinted hydrating oil (hue 616)ZINC OXIDEB.A.I. Biosciences INC.f4eb6b20-7c26-2942-e053-2a95a90abd312025-10-09WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4346f7a-3642-05d8-e053-2a95a90a013d2025-10-09WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4206dad-6a17-2f56-e053-2a95a90a69dc2025-10-09WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf434089c-126f-441c-e053-2995a90ab0c72025-10-09WarningsExact identifier
application number: M020
BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)ZINC OXIDENapoleon PerdisCosmetic Pty Ltdbe64bb40-b1a9-2308-e053-2a95a90a69c82025-10-09WarningsExact identifier
application number: M020
Organys Open Formula SheerZINC OXIDEOrganys Beauty0b3ab551-cb66-cf86-e063-6394a90a7ab42025-10-09WarningsExact identifier
application number: M020
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
application number: M020
Organys Derma Made SheerZINC OXIDEOrganys Beauty0b39f550-bd34-509d-e063-6294a90a51d02025-10-09WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty0b37a73b-73ca-501f-e063-6294a90a62912025-10-09WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty09b8b8c0-4066-9cbe-e063-6394a90aca242025-10-09WarningsExact identifier
application number: M020
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 3)ZINC OXIDEResette, Incdc89ab76-da32-4f6f-e053-2995a90a8bcb2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 4)ZINC OXIDEResette, Incdc89ab0b-d53e-983f-e053-2a95a90a127f2025-10-09WarningsExact identifier
application number: M020
Petroleum-Free Lip BalmOCTINOXATE AND OXYBENZONEMedline Industries, LP6125d98a-6fc7-4f50-924e-3b1f7ee951f42025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 1)ZINC OXIDEResette, Incdc89429a-022c-dd10-e053-2a95a90ac26a2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 2)ZINC OXIDEResette, Incdc89ab76-da2f-4f6f-e053-2995a90a8bcb2025-10-09WarningsExact identifier
application number: M020
Dr Lift SPF 50 Clear StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESpa de Soleil40c11b19-fc91-2033-e063-6394a90a5a5f2025-10-09WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Mineral BabyZINC OXIDEBlack Girl Sunscreen302bccc6-7bf3-cc69-e063-6294a90a625c2025-10-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85585-203-15855850203151.5 g in 1 PACKET (85585-203-15) 1.5 g2021-03-23YesNoCurrent
85585-203-508558502035053 g in 1 BOTTLE, PUMP (85585-203-50) 53 g2025-05-30NoNoCurrent