CERAVE DEVELOPED WITH DERMATOLOGISTS SUNSCREEN BODY BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide lotion

CeraVe Developed with Dermatologists Sunscreen Body Broad Spectrum SPF 50 by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Sunscreen Body Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc., L'Oreal USA Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium dioxide 4.9%

Zinc oxide 4.7%

Purpose

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:
● after 40 minutes of swimming or sweating
● immediately after towel drying
● at least every 2 hours

● 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 othe 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, Cetyl Dimethicone, Dimethicone, Styrene/Acrylates Copolymer, Trimethylsiloxysilicate, Dimethicone PEG-8 Laurate, Isohexadecane, Butylene Glycol, Polysorbate 60, Trisiloxane, Arachidyl Alcohol, Polyhydroxystearic Acid, Hydrated Silica, Ceramide 3, Ceramide 6-II, Ceramide 1, Cholesterol, Phytosphingosine, PEG-100 Stearate, Glyceryl Stearate, Ascorbic Acid, Avena Sativa (Oat) Kernel Extract, Arachidyl Glucoside, Beeswax, Behenyl Alcohol, Benzyl Alcohol, Stearic Acid, Bisabolol, Dipotassium Glycyrrhizate, Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Pantothenic Acid/Yeast Polypeptide, PEG-8, Xanthan Gum, Polyaminopropyl Biguanide, Polymethyl Methacrylate, Alumina, Potassium Sorbate, Retinyl Palmitate, Sodium Lauroyl Lactylate, Carbomer, Tocopheryl Acetate, BHT, Disodium EDTA, Methicone, Methylisothiazolinone, Triethoxycaprylylsilane.

Other information

protect this product from excessive heat and direct sun

Questions?

Toll-free number 1-888-768-2915
www.cerave.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS SUNSCREEN BODY BROAD SPECTRUM SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	4.165 g  in 85 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.995 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)
ISOHEXADECANE (UNII: 918X1OUF1E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TRISILOXANE (UNII: 9G1ZW13R0G)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
OAT (UNII: Z6J799EAJK)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
YELLOW WAX (UNII: 2ZA36H0S2V)
DOCOSANOL (UNII: 9G1OE216XY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
STEARIC ACID (UNII: 4ELV7Z65AP)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
XANTHAN GUM (UNII: TTV12P4NEE)
POLIHEXANIDE (UNII: 322U039GMF)
ALUMINUM OXIDE (UNII: LMI26O6933)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-016-01	85 g in 1 TUBE; Type 0: Not a Combination Product	09/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/15/2017

Labeler - L'Oreal USA Products Inc. (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products, Inc.		624244349	MANUFACTURE(49967-016)