FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Baby Sunscreen Broad Spectrum SPF 45

Manufacturer
L'Oreal USA Products Inc. | Accupac, Inc.
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:16:16

Label at a glance#

ProductCeraVe Developed with Dermatologists Baby Sunscreen Broad Spectrum SPF 45
Active ingredientTITANIUM DIOXIDE, 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 ski aging caused by the sun

Dosage and administration

• apply liberally 15 minutes before sun exposure • reapply: • at least every 2 hours • immediately after towel drying • after 80 minutes of swimming or sweating • children under 6 months: 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 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 7.4%

Zinc oxide 11.4%

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 ski aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product 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:
    • at least every 2 hours
    • immediately after towel drying
    • after 80 minutes of swimming or sweating
  • children under 6 months: 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

water, butyloctyl salicylate, C12-15 alkyl benzoate, glycerin, caprylyl methicone, isohexadecane, triethylhexanoin, mica, glyceryl stearate, trimethylsiloxy silicate, PEG-100 stearate, alumina, polyhydroxystearic acid, aluminum stearate, caprylic/capric triglycerides, polypropyl silsesquioxane, xanthan gum, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, ceramide 3, ceramide 6-II, ceramide 1, aloe barbadensis leaf juice, carthamus tinctorius (safflower) seed oil, niacinamide, hyaluronic acid, sodium hydroxide, phenoxyethanol, cetyl alcohol, isostearic acid, PEG-75 stearate, citric acid, tetrasodium EDTA, propylene glycol stearate, glyceryl isostearate, propylene glycol isostearate, oleth-25, ceteth-25, inulin lauryl carbamate, ceteth-20, steareth-20, stearic acid, ethylhexyl glycerin, glucamine, triethoxycaprylylsilane, sodium lauroyl lactylate, silica, phytosphingosine, cholesterol, carbomer

Other information

OTHER SAFETY INFORMATION

  • protect this product from excessive heat and direct sun

Questions?

OTC - QUESTIONS SECTION

toll-free number 1-888-786-2915  www.CeraVe.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-40149967-401-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
ISOHEXADECANE918X1OUF1EIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
MICAV8A1AW0880IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
XANTHAN GUMTTV12P4NEEIACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
CERAMIDE 15THT33P7X7IACT
ALOE VERA LEAFZY81Z83H0XIACT
SAFFLOWER OIL65UEH262ISIACT
NIACINAMIDE25X51I8RD4IACT
HYALURONIC ACIDS270N0TRQYIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETYL ALCOHOL936JST6JCNIACT
ISOSTEARIC ACIDX33R8U0062IACT
PEG-75 STEARATEOT38R0N74HIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
PROPYLENE GLYCOL MONOSTEARATEMZM1I680W0IACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
OLETH-25R81LKU53DKIACT
CETETH-255KLY4IOG20IACT
CETETH-20I835H2IHHXIACT
STEARETH-20L0Q8IK9E08IACT
STEARIC ACID4ELV7Z65APIACT
GLUCAMINE5QN16UUF80IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT

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
46f28840-0bae-425b-ae19-cdbf508653b03369ac02-9d2a-4a6f-8623-39895efe79f42024-01-29WarningsExact identifier
spl set id: 3369ac02-9d2a-4a6f-8623-39895efe79f4

Reported adverse events (FAERS/openFDA)#

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