FDA.reportPublic FDA data

CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 30

Manufacturer
L’Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.
Effective date
2025-03-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:57

Label at a glance#

ProductCeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 30
Active ingredientHOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
Label structure14 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 in ...

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

Homosalate 10%
Octinoxate 5%
Octisalate 5%
Octocrylene 2%
Zinc oxide 8%

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

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:

  • 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, niacinamide, cetearyl alcohol, glycerin, propanediol, dimethicone, behentrimonium methosulfate, BHT, ceramide NP, ceramide AP, ceramide EOP, carbomer, triethoxycaprylylsilane, triethyl citrate, sodium lauroyl lactylate, sodium hyaluronate, sodium phosphate, cholesterol, aluminum starch octenylsuccinate, phenoxyethanol, disodium phosphate, hydroxyethylcellulose, hydroxyacetophenone, caprylyl glycol, trisodium ethylenediamine disuccinate, phytosphingosine, xanthan gum, polysorbate 60, benzoic acid

Questions or comments?

OTC - QUESTIONS SECTION

Toll-free number 1-888-768-2915

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
49967-346-01CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION12
49967-346-01CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 3060 mL in 1 BOTTLELOTION602
49967-346-02CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 3089 mL in 1 BOTTLELOTION892
49967-346-02CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION12
49967-346-03CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 305 mL in 1 TUBELOTION52
49967-346-04CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 301.5 mL in 1 PACKETLOTION1.52
49967-346-05CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION12
49967-346-05CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 3050 mL in 1 BOTTLELOTION502
49967-346-06CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 30148 mL in 1 TUBELOTION1482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-346CERAVE FACIAL MOISTURIZING WITH SUNSCREEN BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE) LOTION [L’OREAL USA PRODUCTS INC]2Current NDC, 9 package rows20250328_7d9e8c07-d295-4c8e-a52f-bdb509dc489b.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-34649967-346-01, 49967-346-02, 49967-346-03, 49967-346-04, 49967-346-05, 49967-346-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
CETEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
DIMETHICONE92RU3N3Y1OIACT
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
BHT1P9D0Z171KIACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
CARBOMER0A5MM307FCIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
SODIUM HYALURONATEYSE9PPT4THIACT
SODIUM PHOSPHATESE337SVY37IACT
CHOLESTEROL97C5T2UQ7JIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
PHENOXYETHANOLHIE492ZZ3TIACT
DISODIUM PHOSPHATE22ADO53M6FIACT
HYDROXYETHYLCELLULOSET4V6TWG28DIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
XANTHAN GUMTTV12P4NEEIACT
POLYSORBATE 60CAL22UVI4MIACT
BENZOIC ACID8SKN0B0MIMIACT

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 Facial Moisturizing with Sunscreen Broad Spectrum SPF 30HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Inc7d9e8c07-d295-4c8e-a52f-bdb509dc489b2025-03-27WarningsExact identifier
ndc (package): 49967-346-02
ndc (package): 49967-346-06
ndc (package): 49967-346-04
ndc (package): 49967-346-05
ndc (package): 49967-346-01
ndc (package): 49967-346-03
ndc (product): 49967-346
ndc11 (package): 49967034601
ndc11 (package): 49967034606
ndc11 (package): 49967034602
ndc11 (package): 49967034604
ndc11 (package): 49967034605
ndc11 (package): 49967034603
spl id: 3cd1453e-7f51-41ba-9d2f-75a352f1623c
spl set id: 7d9e8c07-d295-4c8e-a52f-bdb509dc489b

Reported adverse events (FAERS/openFDA)#

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