FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Sunscreen Broad Spectrum SPF 50

Manufacturer
L'Oreal USA Products Inc | Autumn Harp, Inc.
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 Sunscreen Broad Spectrum SPF 50
Active ingredientTitanium Dioxide, 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

apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 pr...

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 6%

Zinc oxide 4.7%

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

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

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:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Neopentyl Glycol Diethylhexanoate, Paraffin, Euphobia Cerifera (Candelilla) Wax, Ozokerite, Dimethicone, Beeswax, Polyethylene, Cetyl Alcohol, Ceramide 3, Ceramide 6-II, Ceramide 1, Cholesterol, Phytosphingosine, Sodium Hyaluronate, Polyhydrostearic Acid, Aluminum Hydroxide, Stearic Acid, BHT, Carbomer, Triethoxycaprylylsilane, Isostearic Acid, Sodium Lauroyl Lactylate, Xanthan Gum

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

Questions?

OTC - QUESTIONS SECTION

Toll-free number 1-888-768-2915
www.cerave.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-014-01CeraVe Developed with Dermatologists Sunscreen Broad Spectrum SPF 5013.32 g in 1 BLISTER PACKSTICK13.324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-014CERAVE DEVELOPED WITH DERMATOLOGISTS SUNSCREEN BROAD SPECTRUM SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) STICK [L'OREAL USA PRODUCTS INC]4Current NDC, Legacy NDC, 1 package rows20240101_27d82e37-67ac-4cd3-83c0-fb8388d3a0dd.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
49967-01449967-014-01

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
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
PARAFFINI9O0E3H2ZEIACT
CANDELILLA WAXWL0328HX19IACT
CERESINQ1LS2UJO3AIACT
DIMETHICONE92RU3N3Y1OIACT
YELLOW WAX2ZA36H0S2VIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
CETYL ALCOHOL936JST6JCNIACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
CERAMIDE 15THT33P7X7IACT
CHOLESTEROL97C5T2UQ7JIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
HYALURONATE SODIUMYSE9PPT4THIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ISOSTEARIC ACIDX33R8U0062IACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
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 Developed with Dermatologists Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEL'Oreal USA Products Inc27d82e37-67ac-4cd3-83c0-fb8388d3a0dd2023-12-31WarningsExact identifier
ndc (package): 49967-014-01
ndc (product): 49967-014
ndc11 (package): 49967001401
spl id: ba81290e-6316-4cda-9b20-ac2c7b8ca112
spl set id: 27d82e37-67ac-4cd3-83c0-fb8388d3a0dd

Reported adverse events (FAERS/openFDA)#

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