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Drug Facts

Manufacturer
L'Oreal USA Products, Inc.
Effective date
2025-07-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:06:51

Label at a glance#

ProductCeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80...
Active ingredientHOMOSALATE, 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: after 80 minutes or swimming or sweating immediately after towl drying at least every 2 hours ● 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

Homosalate 6%

Octisalate 5%

Octocrylene 5%

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

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:

  • after 80 minutes or swimming or sweating
  • immediately after towl drying
  • at least every 2 hours

● 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, c12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, triethylhexanoin, polyglyceryl-4 isostearate, dicaprylyl carbonate, ethylene/acrylic acid copolymer, triethanolamine, silica, poly c10-30 alkyl acrylate, stearic acid, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, cetearyl alcohol, triethoxycaprylylsilane, behentrimonium methosulfate, sodium chloride, salicylic acid, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, aluminum stearate, alumina, aluminum hydroxide, iron oxides, phenoxyethanol, p-anisic acid, chlorphenesin, tocoferol, disodium EDTA, disodium stearoyl glutamate, propylene carbonate, citric acid, caprylyl glycol, capryloyl salicylic acid, caprylic/capric triglyceride, diethylhexyl syringylidenemalonate, disteardimonium hectorite, xanthan gum, phytosphingosine, polyhydroxystearic acid, ethylhexylglycerin

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 150 mL tubeimage of 150 mL tubeimage of 150 mL tubeimage of 150 mL tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-832-01CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula89 mL in 1 TUBELOTION893
49967-832-01CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula1 in 1 CARTONLOTION13
49967-832-02CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula5 mL in 1 TUBELOTION53
49967-832-03CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula150 mL in 1 TUBELOTION1503

Products#

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

DailyMed product names page 1 of 2 · 53 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-83249967-832-01, 49967-832-02, 49967-832-03

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 51 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISOHEXADECANE918X1OUF1EIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
DICAPRYLYL ETHER77JZM5516ZIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S)1PEZ3NLY6IIACT
TROLAMINE9O3K93S3TKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
CERAMIDE 15THT33P7X7IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208IACT
NIACINAMIDE25X51I8RD4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
SODIUM CHLORIDE451W47IQ8XIACT
SALICYLIC ACIDO414PZ4LPZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
CHOLESTEROL97C5T2UQ7JIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
ALUMINUM OXIDELMI26O6933IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
FERRIC OXIDE RED1K09F3G675IACT
PHENOXYETHANOLHIE492ZZ3TIACT
P-ANISIC ACID4SB6Y7DMM3IACT
CHLORPHENESINI670DAL4SZIACT
TOCOPHEROLR0ZB2556P8IACT
EDETATE DISODIUM7FLD91C86KIACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT

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 Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid FormulaHOMOSALATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEL'Oreal USA Products, Inc.cd69df67-5231-4a75-a9fb-a8669806a8922025-07-08WarningsExact identifier
ndc (package): 49967-832-02
ndc (package): 49967-832-01
ndc (package): 49967-832-03
ndc (product): 49967-832
ndc11 (package): 49967083203
ndc11 (package): 49967083202
ndc11 (package): 49967083201
spl id: 97f682ae-8958-4ce4-9fe7-30ca215087d5
spl set id: cd69df67-5231-4a75-a9fb-a8669806a892

Reported adverse events (FAERS/openFDA)#

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