FDA.reportPublic FDA data

CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen

Manufacturer
L'Oreal USA Products, Inc. | Universal Packaging Systems, Inc.
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:06:12

Label at a glance#

ProductCeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen
Active ingredientHomosalate, MERADIMATE, Octinoxate, Octocrylene, Zinc oxide
Label structure13 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: ● limi...

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%

Meradimate 5%

Octinoxate 5%

Octocrylene 2%

Zinc oxide 6.3%

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, niacinamide, cetearyl alcohol, glycerin, dimethicone, behentrimonium methosulfate, ceramide 3,  ceramide 6-II, ceramide 1, hyaluronic acid, sodium hydroxide, aluminum starch octenylsuccinate,  hydroxyethylcellulose, methylparaben, disodium EDTA, propylparaben, sodium lauroyl lactylate, phytosphingosine, cholesterol, carbomer, xanthan gum

Other information

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Toll-free number 1-888-768-2915

www.CeraVe.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

image of a carton
image of a carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-015-01CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen89 mL in 1 BOTTLE, PLASTICLOTION897
49967-015-01CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION17
49967-015-02CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen60 mL in 1 BOTTLE, PLASTICLOTION607
49967-015-02CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION17
49967-015-03CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen5 mL in 1 TUBELOTION57
49967-015-04CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen1.5 mL in 1 PACKETLOTION1.57
49967-015-05CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION17
49967-015-05CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen50 mL in 1 BOTTLELOTION507
49967-015-06CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION17
49967-015-06CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen148 mL in 1 TUBELOTION1487

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-015CERAVE AM FACIAL MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS, INC.]7Current NDC, Legacy NDC, 10 package rows20240101_2138f86b-3937-4c2b-9568-d40a745b637d.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-01549967-015-01, 49967-015-02, 49967-015-03, 49967-015-04, 49967-015-05, 49967-015-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
HomosalateV06SV4M95SACTIB
MERADIMATEJ9QGD60OUZACTIB
Octinoxate4Y5P7MUD51ACTIB
Octocrylene5A68WGF6WMACTIB
Zinc oxideSOI2LOH54ZACTIB
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
CERAMIDE 34370DF050BIACT
CERAMIDE 6 IIF1X8L2B00JIACT
CERAMIDE 15THT33P7X7IACT
HYALURONIC ACIDS270N0TRQYIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45IACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CHOLESTEROL97C5T2UQ7JIACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)F68VH75CJCIACT
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 AM Facial Moisturizing Broad Spectrum SPF 30 SunscreenHOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENEL'Oreal USA Products, Inc.2138f86b-3937-4c2b-9568-d40a745b637d2023-12-31WarningsExact identifier
ndc (package): 49967-015-02
ndc (package): 49967-015-04
ndc (package): 49967-015-05
ndc (package): 49967-015-01
ndc (package): 49967-015-03
ndc (package): 49967-015-06
ndc (product): 49967-015
ndc11 (package): 49967001503
ndc11 (package): 49967001502
ndc11 (package): 49967001505
ndc11 (package): 49967001504
ndc11 (package): 49967001501
ndc11 (package): 49967001506
spl id: 9e408aae-0e5e-476f-aefe-3b813f3934b7
spl set id: 2138f86b-3937-4c2b-9568-d40a745b637d

Reported adverse events (FAERS/openFDA)#

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