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Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:06:16

Label at a glance#

ProductCerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Face Lightweight, non-greasy feel 3 essential ceramid...
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

For sunscreen 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 ...

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 9%

Zinc oxide 7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

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

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:

  • 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.-2p.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, glycerin, C12-15 alkyl benzoate, dimethicone, isododecane, styrene/acrylates copolymer, glyceryl stearate, butyloctyl salicylate, dicaprylyl carbonate, propanediol, stearic acid, aluminum hydroxide, PEG-100 stearate, sorbitan stearate, niacinamide, PEG-8 laurate, ceramide NP, ceramide AP, ceramide E0P, sobitan isostearate, carbomer, cetearyl alcohol, ceteareth-20, triethoxycaprylylsilane, dimethiconol, sodium citrate, sodium lauroyl lactylate, sodium dodecylbenzenesulfonate, myristic acid, sodium hyaluronate, cholesterol, palmitic acid, phenoxyethanol, chlorphenesin, tocopherol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, caprylyl glycol, citric acid, panthenol, xanthan gum, phytosophingosine, polyhydroxystearic acid, polysorbate 60, ethylhexylglycerin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-959-01Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Face Lightweight, non-greasy feel 3 essential ceramides niacinamide Mineral75 mL in 1 TUBELOTION753
49967-959-01Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Face Lightweight, non-greasy feel 3 essential ceramides niacinamide Mineral1 in 1 CARTONLOTION13
49967-959-02Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Face Lightweight, non-greasy feel 3 essential ceramides niacinamide Mineral5 mL in 1 TUBELOTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-959CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 50 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]3Current NDC, Legacy NDC, 3 package rows20240101_bcf5e724-b40a-49dd-8a09-57cefd7f65ad.zip

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
49967-95949967-959-01, 49967-959-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
ISODODECANEA8289P68Y2IACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
PROPANEDIOL5965N8W85TIACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PEG-100 STEARATEYD01N1999RIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
NIACINAMIDE25X51I8RD4IACT
PEG-8 LAURATE762O8IWA10IACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
CERAMIDE 15THT33P7X7IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
MYRISTIC ACID0I3V7S25AWIACT
HYALURONATE SODIUMYSE9PPT4THIACT
CHOLESTEROL97C5T2UQ7JIACT
PALMITIC ACID2V16EO95H1IACT
phenoxyethanolHIE492ZZ3TIACT
CHLORPHENESINI670DAL4SZIACT
TOCOPHEROLR0ZB2556P8IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
PANTHENOLWV9CM0O67ZIACT

Source Document#

Source XML · Source PDF

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 Dermatologists Hydrating Sunscreen SPF 50 Face Lightweight, non-greasy feel 3 essential ceramides niacinamide MineralTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incbcf5e724-b40a-49dd-8a09-57cefd7f65ad2023-12-31WarningsExact identifier
ndc (package): 49967-959-02
ndc (package): 49967-959-01
ndc (product): 49967-959
ndc11 (package): 49967095901
ndc11 (package): 49967095902
spl id: 537d1f29-e636-45c8-b507-6b49753465a8
spl set id: bcf5e724-b40a-49dd-8a09-57cefd7f65ad

Reported adverse events (FAERS/openFDA)#

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