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 195 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum 30 Mineral Sunscreen Face 1.7 OZTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3b1729c5-d8ca-94c7-e063-6394a90a67a52025-08-18WarningsExact identifier
application number: M020
CoTZ KidsZINC OXIDEFallien Cosmeceuticals, LTD.3ca914e2-cd53-42bf-e063-6294a90a70822025-08-18WarningsExact identifier
application number: M020
Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3b1a0596-b852-16be-e063-6394a90a34982025-08-18WarningsExact identifier
application number: M020
Sun Bum Signature Clear High Performance Sunscreen Broad Spectrum SPF 50 1.5 OZOCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3b29dbfc-0b92-eb0f-e063-6294a90a16e12025-08-18WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Sunscreen 32 OZZINC OXIDESun Bum, LLC3b2cb7cf-7e2c-0fd2-e063-6294a90a3b172025-08-18WarningsExact identifier
application number: M020
Sun Bum Sunscreen Oil 50 5 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b2b4ba0-3f89-0a04-e063-6294a90ac1c02025-08-18WarningsExact identifier
application number: M020
Sun Bum Signature Sunscreen Premium Zinc Lip Balm Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3ca9e9d3-1c73-7bd6-e063-6394a90ad2042025-08-18WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 50 Essential Scent of Sunshine Zinc Oxide Continuous SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3caaea85-0dfe-6f69-e063-6294a90a7d4a2025-08-18WarningsExact identifier
application number: M020
PLAY Lip Shield SPF 30 - MintAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLC3cab1a7d-6226-9eba-e063-6294a90a8c4d2025-08-18WarningsExact identifier
application number: M020
Sun Bum Broad Spectrum SPF 30 5 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cad0757-3155-c716-e063-6294a90ad7a92025-08-18WarningsExact identifier
application number: M020
Cica Redness Solution SunscreenZINC OXIDEMeebak Beauty, Inc15eea1eb-9468-4611-915d-e43112c4a4f52025-08-18WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE/OCTOCRYLENEEdgewell Personal Care Brands LLC3c936ed0-ab7a-ccec-e063-6294a90afd932025-08-17WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE OCTOCRYLENE OXYBENZONEEdgewell Personal Care Brands LLC0f772b91-e67b-46cf-e054-00144ff8d46c2025-08-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, OCTOCRYLENE, OXYBENZONEEdgewellPersonal Care Brands LLC353353b9-54f8-4300-9632-7615de3940762025-08-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC0c6aeadb-f61d-29e3-e063-6294a90a74732025-08-17WarningsExact identifier
application number: M020
MOISTURE SURGE SPFAVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATECLINIQUE LABORATORIES LLCec921e21-db68-db77-e053-2a95a90a57812025-08-15WarningsExact identifier
application number: M020
Olay Invisible Sunscreen Facial Primer plus Sunscreen Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company3c69f096-1575-309b-e063-6394a90a72292025-08-15WarningsExact identifier
application number: M020
MOISTURE SURGE CC BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCea4d564f-ac64-abac-e053-2a95a90a8abb2025-08-15WarningsExact identifier
application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Sunset Cove CardedHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3ac67c26-d56e-32a9-e063-6294a90a10482025-08-15WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDESun Bum, LLC3aa13423-045a-7227-e063-6294a90ae49b2025-08-15WarningsExact 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