CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day

Manufacturer
L'Oreal USA Products Inc. | Accupac, LLC
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:06:13

Label at a glance#

ProductCeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure10 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

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor 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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Zinc Oxide 10.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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 on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if 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

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor
  • 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

Other information

OTHER SAFETY INFORMATION

protect this product packaging from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cyclomethicone, pentylene glycol, phenyl trimethicone, cetearyl alcohol, PEG-40 stearate,

dimethicone, glycerin, stearyl alcohol, phenoxyethanol, hydroxyethyl acrylate, sodium acryloyldimethyl taurate copolymer, ceramide 3, ceramide 6-II, ceramide 1, potassium cetyl phosphate, squalane, phytosphingosine, cholesterol, lecithin, hydrogenated palm glycerides, behentrimonium methosulfate, polysorbate 60, hyaluronic acid, retinol, disodium EDTA, xanthan gum, iris florentina root extract, ceteareth-20, polysilicone-11, polysorbate 20, chlorphenesin, sodium lauroyl lactylate, tetrahexyldecyl

ascorbate, alcohol, butylene glycol, ethylhexylglycerin, dimethicone crosspolymer-3, sodium polyacrylate, sodium hydroxide, carbomer, citric acid

Questions?

OTC - QUESTIONS SECTION

Toll-free number 1-888-768-2915

CeraVe.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-900-01CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day1 in 1 CARTONCREAM14
49967-900-01CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day50 g in 1 BOTTLE, PUMPCREAM504
49967-900-02CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day5 g in 1 TUBECREAM54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-900CERAVE DEVELOPED WITH DERMATOLOGISTS SKIN RENEWING BROAD SPECTRUM SPF 30 DAY (OCTINOXATE AND ZINC OXIDE) CREAM [L'OREAL USA PRODUCTS INC.]4Current NDC, Legacy NDC, 3 package rows20240101_50542a3b-2ef0-452f-b463-79b41e10d1e0.zip

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-90049967-900-01, 49967-900-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

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 Skin Renewing Broad Spectrum SPF 30 DayOCTINOXATE AND ZINC OXIDEL'Oreal USA Products Inc.50542a3b-2ef0-452f-b463-79b41e10d1e02023-12-31WarningsExact identifier
ndc (package): 49967-900-01
ndc (package): 49967-900-02
ndc (product): 49967-900
ndc11 (package): 49967090002
ndc11 (package): 49967090001
spl id: 246b0293-ab86-44b4-b615-fef215ef0ce7
spl set id: 50542a3b-2ef0-452f-b463-79b41e10d1e0

Reported adverse events (FAERS/openFDA)#

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