CERAVE SKIN RENEWING DAY CREAM WITH BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate and zinc oxide lotion 
Bausch Health US LLC

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.

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Drug Facts

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 800-321-4576

CeraVe.com

Package/Label Principal Display Panel

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

NEW

Skin Renewing

Day

Cream

With Sunscreen

Broad Spectrum

SPF 30

Clinically shown

non-irritating

With 3 essential ceramides

& hyaluronic acid

ENCAPSULATED

RETINOL

Net Wt. 1.76 OZ (50 g)

CeraVe Skin Renewing Day Cream SPF 30 Carton
CERAVE  SKIN RENEWING DAY CREAM WITH BROAD SPECTRUM SPF 30 SUNSCREEN
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-2490
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE105 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
SQUALANE (UNII: GW89575KF9)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
RETINOL (UNII: G2SH0XKK91)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
IRIS X GERMANICA NOTHOVAR. FLORENTINA ROOT (UNII: M30XO5X4XD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-2490-021 in 1 CARTON11/07/201608/01/2017
150 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/07/201608/01/2017
Labeler - Bausch Health US LLC (831922468)

Revised: 1/2017
 
Bausch Health US LLC