FDA.reportPublic FDA data

CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50

Product NDC
82046-894
11-digit product format
820460894
Labeler code
82046
Product ID
82046-894_fa2e67ee-c9c9-40cf-ae5f-122caa7d0196
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium dioxide and Zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
L�Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-15
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
26.6; 153.5 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE26.6 mg/mL
ZINC OXIDE153.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
372894af-bed7-474f-95d4-69a8c3f215efAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82046-894-01CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 5048 mL in 1 TUBELOTION481
82046-894-01CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 501 in 1 CARTONLOTION11
82046-894-02CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 5015 in 1 CARTONLOTION151
82046-894-02CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 505 mL in 1 TUBELOTION51

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 52 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris UV Expert Aquagel Defense 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc500e58f-38b0-454e-8923-912844276b172026-03-20WarningsExact identifier
application number: M020
Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZERTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED4a1ec566-549f-45f2-a43d-dacfc72633612026-03-20WarningsExact identifier
application number: M020
SOJO sunscreenZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4d44efb6-abc5-c346-e063-6394a90a60232026-03-19WarningsExact identifier
application number: M020
VRC Lip balm SPF15ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4d588fbe-e61a-2264-e063-6394a90aa0602026-03-19WarningsExact identifier
application number: M020
SOjO Lip balm SPF15ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4d5ed865-fff2-ee44-e063-6294a90a67e22026-03-19WarningsExact identifier
application number: M020
ActivDerm Radiant Shield Broad Spectrum SPF 40ZINC OXIDEACTIVDERM LLC4d6307f1-bab6-5f44-e063-6294a90a8e362026-03-19WarningsExact identifier
application number: M020
Mad Robbit DEFEND SPF30SUNSCREENMAD RABBIT TATTOO, INC.bf853d54-ecd9-40cc-9f10-cb546bfb89332026-03-19WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30SKNVcare, LLC4d67dfb4-3607-2af6-e063-6294a90ae01a2026-03-19WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
application number: M020
GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREENZINC OXIDECLIO COSMETICS Co., Ltd.c7b13245-a3e0-4d53-b7fe-9b2c9707ab9e2026-03-18WarningsExact identifier
application number: M020
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 BURNT MAPLEZINC OXIDECOSMAX USA4d318f51-1a43-44d5-e063-6394a90a49702026-03-17WarningsExact identifier
application number: M020
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 HAZY MAUVEZINC OXIDECOSMAX USA4d319110-e6a4-1ad3-e063-6394a90aa99c2026-03-17WarningsExact identifier
application number: M020
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 SUNLIT CORALZINC OXIDECOSMAX USA4d31b201-9d6a-730a-e063-6394a90a67002026-03-17WarningsExact identifier
application number: M020
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d39b64c-2e27-afed-e063-6394a90a38122026-03-17WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC4d39ed7a-ca80-893c-e063-6294a90a03e72026-03-17WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
application number: M020
Avobenzone, Homosalate, Octisalate, OctocryleneAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company4d3a36b9-7d63-01ac-e063-6294a90af4fb2026-03-17Warnings, Adverse reactionsExact identifier
application number: M020
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3a460b-1b98-2906-e063-6294a90a36692026-03-17WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30SKNVCARE, LLC4d3ad051-3729-06fd-e063-6394a90ad0fe2026-03-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82046-894-01820460894011 TUBE in 1 CARTON (82046-894-01) / 48 mL in 1 TUBE1 tube2025-12-15NoNoCurrent
82046-894-028204608940215 TUBE in 1 CARTON (82046-894-02) / 5 mL in 1 TUBE15 tube2025-12-15NoNoCurrent