CERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45- titanium dioxide 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

Titanium dioxide 7.4%

Zinc oxide 11.4%

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

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.

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
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

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

protect this product from excessive heat and direct sun

Questions?

toll-free number 800-321-4576 www.CeraVe.com

Package/Label Principal Display Panel

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

baby

Sunscreen

Broad Spectrum SPF 45

LOTION SPF 45

Naturally sourced

sunscreen ingredients

With essential ceramides

and soothing aloe

Hypoallergenic

Paraben &

sulfate free

Fragrance free

Water resistant

(80 minutes)

NET WT. 3.5 OZ (99 g)

[Icon - National Eczema Association seal]

CeraVe Baby Sunscreen 3.5 OZ Carton
CERAVE  BABY SUNSCREEN BROAD SPECTRUM SPF 45
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-2224
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE74 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE114 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
NIACINAMIDE (UNII: 25X51I8RD4)  
HYALURONIC ACID (UNII: S270N0TRQY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
PEG-75 STEARATE (UNII: OT38R0N74H)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
OLETH-25 (UNII: R81LKU53DK)  
CETETH-25 (UNII: 5KLY4IOG20)  
CETETH-20 (UNII: I835H2IHHX)  
STEARETH-20 (UNII: L0Q8IK9E08)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLUCAMINE (UNII: 5QN16UUF80)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-2224-0199 g in 1 TUBE; Type 0: Not a Combination Product11/01/201408/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/201408/01/2017
Labeler - Bausch Health US LLC (831922468)

Revised: 2/2017
 
Bausch Health US LLC