FDA.reportPublic FDA data

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 291 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tanning Club Golden Glow Tanning Oil SPF-15AVOBENZONE, OCTISALATE, OCTOCRYLENETANNING CLUB, LLC748a9933-02a3-48c1-8636-8f0468f66a132024-07-17WarningsExact identifier
application number: M020
Tan De Soleil Orange Tanning Balm SPF 6HOMOSALATE, OCTISALATETANNING CLUB, LLC5343f359-6074-467c-99bb-f08a7ca2df412024-07-17WarningsExact identifier
application number: M020
Tanning Club Tanning SPF-8AVOBENZONE, OCTOCRYLENETANNING CLUB, LLCbbf9d61e-f2e6-4fde-baad-c412091c60b62024-07-17WarningsExact identifier
application number: M020
Mackenzies SPF 40 Ocean Safe SunscreenZINC OXIDENaturally Uncommon LLC1c314b70-45a7-1bd1-e063-6294a90a0d6b2024-07-17WarningsExact identifier
application number: M020
Bitchstix Eucalyptus Mint SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d764eb8-a0a7-d034-e063-6394a90aef242024-07-17WarningsExact identifier
application number: M020
Bitchstix Acai Berry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d765c28-f9da-15b6-e063-6394a90a057f2024-07-17WarningsExact identifier
application number: M020
Bitchstix Banana Kiwi SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76e972-4fc1-9438-e063-6294a90a58452024-07-17WarningsExact identifier
application number: M020
Bitchstix Pineapple Twist SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7699f4-3088-9436-e063-6294a90ab8522024-07-17WarningsExact identifier
application number: M020
Bitchstix Black Cherry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76824a-eac4-2d1f-e063-6294a90a8e662024-07-17WarningsExact identifier
application number: M020
Bitchstix Classic Coconut SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76aed7-308b-5cc5-e063-6394a90a45432024-07-17WarningsExact identifier
application number: M020
Bitchstix Pink Watermelon SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76e9b7-95af-6015-e063-6294a90a6f192024-07-17WarningsExact identifier
application number: M020
Bitchstix Vanilla Creme SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7713a9-de97-f0ff-e063-6294a90a80032024-07-17WarningsExact identifier
application number: M020
Bitchstix Grapefruit SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7723c7-984a-a789-e063-6394a90abdc42024-07-17WarningsExact identifier
application number: M020
Bitchstix Matcha and Aloe SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d771406-7c59-6052-e063-6394a90a01e62024-07-17WarningsExact identifier
application number: M020
Bitchstix Lemon Twist SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d770a10-a9fa-94c4-e063-6294a90a137a2024-07-17WarningsExact identifier
application number: M020
Bitchstix Mango SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77866e-64f2-86d6-e063-6394a90a12922024-07-17WarningsExact identifier
application number: M020
Bitchstix Peachy Peach SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77c31e-c606-74b7-e063-6294a90a2cee2024-07-17WarningsExact identifier
application number: M020
Bitchstix Pink Lemon SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77d785-56eb-e865-e063-6394a90acd012024-07-17WarningsExact identifier
application number: M020
Bitchstix Pomegranate SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77e9c3-cffd-0bb6-e063-6294a90aacd12024-07-17WarningsExact identifier
application number: M020
Bitchstix Strawberry Dragon Fruit SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77f460-e7be-30fe-e063-6394a90a8f1e2024-07-17WarningsExact 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