Activated Mineral Sunscreen Tinted

Product NDC
83083-002
11-digit product format
830830002
Labeler code
83083
Product ID
83083-002_452053bf-8b70-6550-e063-6294a90a23be
Type
HUMAN OTC DRUG
Nonproprietary name
Activated Mineral Sunscreen Tinted
Dosage form
CREAM
Route
TOPICAL
Labeler
Reve Skincare LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-25
Substance
ZINC OXIDE
Active strength
142.8 mg/mL
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
Activated Mineral Sunscreen Tinted
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE142.8 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
312a32a7-d253-f10c-e063-6294a90a803aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83083-002-50Activated Mineral Sunscreen Tinted1 in 1 CARTONCREAM12
83083-002-50Activated Mineral Sunscreen Tinted50 mL in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83083-002ACTIVATED MINERAL SUNSCREEN TINTED CREAM [REVE SKINCARE LLC]1Current NDC, 2 package rows20250327_312a32a7-d253-f10c-e063-6294a90a803a.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 346 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antioxidant Sunscreen SPF 40OCTINOXATE AND ZINC OXIDETopiderm, Inc.2686378c-8827-47fb-b3ed-07438bd4e9e22019-11-13WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool VanillaOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASd701c221-9f68-47ff-b766-2f4f1998649f2019-10-08WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 AmberOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS7f5e6872-4d26-410e-8afe-16a016f9a3992019-10-08WarningsExact identifier
application number: M020
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm IvoryOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS1124ba7d-a328-409b-8c88-e74bb3e501f52019-10-08WarningsExact identifier
application number: M020
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 HoneyOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS9c407dc7-fcde-4660-9a06-57bd8a6b867d2019-10-08WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 ChestnutOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASf07e8bb2-30ae-4337-ad60-84f55f2ff3542019-10-08WarningsExact identifier
application number: M020
Thinkbaby Sunscreen SPF 30ZINC OXIDEthinkOperations,LLC86249f33-e635-4455-a039-3a25aa3478df2019-03-25WarningsExact identifier
application number: M020
Sun Defense Mineral Sunscreen SPF 30 FaceZINC OXIDEderma e635ae850-7ce4-4cb7-bdaf-bec00904ca022018-11-12WarningsExact identifier
application number: M020
Thinksport Sunscreen SPF 30ZINC OXIDEthinkOperations,LLCa8591509-65f7-4e62-8642-4b8e63f1fef32018-11-08WarningsExact identifier
application number: M020
Essential Defense Everyday Clear Broad Spectrum SPF 47 SunscreenZINC OXIDE AND OCTINOXATEAllergan, Inc.bc872876-20e7-40cb-b79d-68998883681a2016-03-01WarningsExact identifier
application number: M020
TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.6a996e03-907f-4e6a-b232-0892b86956b02015-08-21WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD.30468afc-9616-4765-b046-12e97a0a78272010-12-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83083-002-50830830002501 TUBE in 1 CARTON (83083-002-50) / 50 mL in 1 TUBE1 tube2025-03-25NoNoCurrent