CERAVE SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide stick 
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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CeraVe®
Sunscreen Stick SPF 50

Drug Facts

Active IngredientsPurpose

Titanium Dioxide 6%

Sunscreen

Zinc Oxide 4.7%

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: 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

C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Neopentyl Glycol Diethylhexanoate, Paraffin, Euphobia Cerifera (Candelilla) Wax, Ozokerite, Dimethicone, Beeswax, Polyethylene, Cetyl Alcohol, Ceramide 3, Ceramide 6-II, Ceramide 1, Cholesterol, Phytosphingosine, Sodium Hyaluronate, Polyhydrostearic Acid, Aluminum Hydroxide, Stearic Acid, BHT, Carbomer, Triethoxycaprylylsilane, Isostearic Acid, Sodium Lauroyl Lactylate, Xanthan Gum

Other Information

•
Protect this product from excessive heat and direct sun.

Questions?

Toll-free number (800) 321-4576
www.cerave.com

PRINCIPAL DISPLAY PANEL - 0.47 OZ Sunscreen Stick SPF 50

CeraVe®
DEVELOPED WITH DERMATOLOGISTS

Sunscreen
BROAD SPECTRUM SPF 50

STICK SPF 50

InVisibleZinc

Net Wt. 0.47 OZ (13.32 g)

CeraVe SPF 50 Sunscreen Stick Blister Card
CERAVE  SUNSCREEN BROAD SPECTRUM SPF 50
titanium dioxide, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-2208
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.80 g  in 13.32 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.63 g  in 13.32 g
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
PARAFFIN (UNII: I9O0E3H2ZE)  
CANDELILLA WAX (UNII: WL0328HX19)  
CERESIN (UNII: Q1LS2UJO3A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-2208-0113.32 g in 1 BLISTER PACK; Type 0: Not a Combination Product12/03/201208/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/03/201208/01/2017
Labeler - Bausch Health US LLC (831922468)

Revised: 2/2017
Document Id: eaab9ffa-bef2-4b84-a56c-cc0a5dbad828
Set id: 5251aa24-287e-4a23-a6a7-ef6d696904f6
Version: 3
Effective Time: 20170217
 
Bausch Health US LLC