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
2027-12-31

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 230 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a87c6b-3c7d-5942-e063-6294a90aa4522025-02-06WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.02a671ed-485d-d6b7-e063-6394a90ad4af2025-02-06WarningsExact identifier
application number: M020
Dr.Jart Cicapair Tiger Grass Camo DropsZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cf0522-a3c1-aea8-e063-6294a90aabfe2025-02-06WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY SUN FLUIDHOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEHave & Be Co., Ltd.02a72c6d-da42-14b2-e063-6394a90af5cb2025-02-06WarningsExact identifier
application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Glow SerumZINC OXIDE 20%EMMA LEWISHAM US, INC.2b097709-913f-d906-e063-6394a90a04462025-02-05WarningsExact identifier
application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Face CreamZINC OXIDE 20%EMMA LEWISHAM US, INC.2c703df8-23af-d630-e063-6294a90a1a242025-02-05WarningsExact identifier
application number: M020
doTERRA SunZINC OXIDEdoTERRA International, LLCdd308fef-e312-4ced-e053-2995a90a76fd2025-02-05WarningsExact identifier
application number: M020
OrgaPlus Ultra Pure Sun EX 15gOCTINOXATE, OCTISALATE, OCTOCRYLENEBLUEZONWIDE CO.,LTDb686ef63-7eee-4a4d-a559-417d8b09cc4f2025-02-05WarningsExact identifier
application number: M020
OrgaPlus Ultra Pure Sun EX 22gOCTINOXATE, OCTISALATE, OCTOCRYLENEBLUEZONWIDE CO.,LTDd3c422f6-a83d-48fc-94fc-2749666426c82025-02-05WarningsExact identifier
application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Body CreamZINC OXIDE 20%EMMA LEWISHAM US, INC.2d65b2d0-7013-d0ad-e063-6394a90ad4c22025-02-05WarningsExact identifier
application number: M020
Olay Sun Hydrating Facial Moisturizer with Sunscreen SPF 30 Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company2d6a6fed-a26e-e3a6-e063-6394a90ae2c72025-02-05WarningsExact identifier
application number: M020
Brush On Block Sheer Genius SPF 50 Mineral MoistureZINC OXIDESPF Ventures, LLC2d4b8c92-b932-89a7-e063-6394a90a621d2025-02-04WarningsExact identifier
application number: M020
Seven Thirty Daily Habit Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY30ca8f9d-b6a5-4af0-9d7b-487212e40e632025-02-03WarningsExact identifier
application number: M020
Atlanta Acne Specialist Everyday Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY3057f8ad-5850-49a0-b44d-3a1da84126e32025-02-03WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD.2d3faa43-0d78-58de-e063-6294a90a0b172025-02-03WarningsExact identifier
application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD2d40099a-2cfa-1d99-e063-6394a90a36a62025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 ALMOND WD1HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.4ebd7db8-7e6c-46ed-9d0c-6f9f81ea65fe2025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CARAMEL D16HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.e4466bcb-278a-44bb-a87b-479c14037e762025-02-03WarningsExact identifier
application number: M020
JJAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 BISQUE MDN4HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.282c72a8-bcfa-417f-a79d-9dcf688588332025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 EARTH ND18HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.15eae33b-e8f5-4334-8bf9-fa02ed6ff46d2025-02-03WarningsExact 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