CERAVE DEVELOPED WITH DERMATOLOGISTS BABY SUNSCREEN BROAD SPECTRUM SPF 45- titanium dioxide and zinc oxide lotion 
L'Oreal USA Products Inc.

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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 ski 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 1-888-786-2915 www.CeraVe.com

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CERAVE DEVELOPED WITH DERMATOLOGISTS BABY SUNSCREEN BROAD SPECTRUM SPF 45 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-401
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:49967-401-0199 g in 1 TUBE; Type 0: Not a Combination Product10/25/201705/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/25/201705/31/2023
Labeler - L'Oreal USA Products Inc. (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663MANUFACTURE(49967-401)

Revised: 1/2024
 
L'Oreal USA Products Inc.