CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day: Package Insert and Label Information

CERAVE DEVELOPED WITH DERMATOLOGISTS SKIN RENEWING BROAD SPECTRUM SPF 30 DAY- octinoxate and zinc oxide cream
L’Oreal USA Products Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients

Octinoxate 7.5%

Zinc Oxide 10.5%

Purpose

Sunscreen

Sunscreen

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

Warnings

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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

protect this product packaging from excessive heat and direct sun

Inactive ingredients

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?

Toll-free number 1-888-768-2915

CeraVe.com

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CERAVE DEVELOPED WITH DERMATOLOGISTS SKIN RENEWING BROAD SPECTRUM SPF 30 DAY
octinoxate and zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-900
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 105 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE
PENTYLENE GLYCOL
PHENYL TRIMETHICONE
CETOSTEARYL ALCOHOL
PEG-40 STEARATE
DIMETHICONE
GLYCERIN
STEARYL ALCOHOL
PHENOXYETHANOL
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
CERAMIDE NP
CERAMIDE AP
CERAMIDE 1
POTASSIUM CETYL PHOSPHATE
SQUALANE
PHYTOSPHINGOSINE
CHOLESTEROL
LECITHIN, SOYBEAN
HYDROGENATED PALM GLYCERIDES
BEHENTRIMONIUM METHOSULFATE
POLYSORBATE 60
HYALURONIC ACID
RETINOL
EDETATE DISODIUM
XANTHAN GUM
IRIS GERMANICA VAR. FLORENTINA ROOT
POLYOXYL 20 CETOSTEARYL ETHER
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
POLYSORBATE 20
CHLORPHENESIN
SODIUM LAUROYL LACTYLATE
TETRAHEXYLDECYL ASCORBATE
ALCOHOL
BUTYLENE GLYCOL
ETHYLHEXYLGLYCERIN
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
SODIUM POLYACRYLATE (8000 MW)
SODIUM HYDROXIDE
CARBOXYPOLYMETHYLENE
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-900-01 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 50 g in 1 BOTTLE, PUMP This package is contained within the CARTON (49967-900-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 08/28/2017
Labeler — L’Oreal USA Products Inc. (002136794)
Establishment
Name Address ID/FEI Operations
L’Oreal USA Products, Inc. 624244349 MANUFACTURE (49967-900)

Revised: 01/2020 L’Oreal USA Products Inc.

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