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Drug Facts

Manufacturer
L’Oreal USA Products Inc | L'Oreal USA Products, Inc.
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:22:56

Label at a glance#

ProductCERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD ...
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure16 sections

Dosage and administration

For sunscreen use: shake well before use apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures inc...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 2.66%

Zinc oxide 15.35%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product,

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  •    limit time in the sun, especially from 10 a.m. - 2 p.m.
  •    wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, C15-19 allkane, glycerin, dicaprylyl carbonate, niacinamide, propanediol, cetearyl isononanoate, polyhydroxystearic acid, dimethicone, ethylhexyl methoxycrylene, cellulose, triethylhexanoin, isohexadecane, triethoxycaprylylsilane, steareth-20, silica, steareth-2, ceramide NP, ceramide AP, ceramide EOP, carbomer, glyceryl stearate, cetearyl alcohol, behentrimonium methosulfate, triethyl citrate, sodium lauroyl lactylate, cholesterol, aluminum stearate, alumina, chlorphenesin, tocopherol, hydroxyacetophenone, caprylyl glycol, caprylic/capric triglyceride, citric acid, diethylhexyl syringylidenemalonate, panthenol, xanthan gum, phytosphingosine, polysorbate 20, acrylates/C10-30 alkyl acrylate crosspolymer, benzoic acid

Questions or comments?

OTC - QUESTIONS SECTION

Toll-free number 1-888-768-2915

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

48 mL tube48 mL tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

48 mL carton48 mL carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 mL tube5 mL tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 mL pack5 mL pack

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82046-89482046-894-01, 82046-894-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
C15-19 ALKANECI87N1IM01IACT
GLYCERINPDC6A3C0OXIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
NIACINAMIDE25X51I8RD4IACT
PROPANEDIOL5965N8W85TIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
POWDERED CELLULOSESMD1X3XO9MIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
ISOHEXADECANE918X1OUF1EIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
STEARETH-20L0Q8IK9E08IACT
SILICAETJ7Z6XBU4IACT
STEARETH-2V56DFE46J5IACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
CERAMIDE 15THT33P7X7IACT
CARBOMER0A5MM307FCIACT
GLYCERYL STEARATE230OU9XXE4IACT
CETEARYL ALCOHOL2DMT128M1SIACT
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
CHOLESTEROL97C5T2UQ7JIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
ALUMINALMI26O6933IACT
CHLORPHENESINI670DAL4SZIACT
TOCOPHEROLR0ZB2556P8IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CITRIC ACID2968PHW8QPIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
PANTHENOLWV9CM0O67ZIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc372894af-bed7-474f-95d4-69a8c3f215ef2025-11-14WarningsExact identifier
ndc (package): 82046-894-01
ndc (package): 82046-894-02
ndc (product): 82046-894
ndc11 (package): 82046089402
ndc11 (package): 82046089401
spl id: fa2e67ee-c9c9-40cf-ae5f-122caa7d0196
spl set id: 372894af-bed7-474f-95d4-69a8c3f215ef

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.