BABY PURE AND GENTLE SPF 60 SUNSCREEN- titanium dioxide - 6.00% zinc oxide - 4.70% stick 
CVS

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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CVS Health

Drug Facts

Active ingredients                     Purpose

Titanium Dioxide - 6.00%          Sunscreen 
Zinc Oxide - 4.70%                    Sunscreen

Uses

 helps prevent sunburn

Warnings
For external use only

Do not use on damage 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 the children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
  - after 80 minutes of swimming or sweating
  - immediately after towel drying
  - at least every 2 hours
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 SPF 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 sleeve shirts, pants, hats, and sunglasses
• children under 6 month: Ask a doctor

Inactive ingredients

Aluminum Hydroxide, Beeswax, BHT, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cetyl Alcohol, Dimethicone, Euphorbia Cerifera (Candelilla) Wax, Isostearic Acid, Neopentyl Glycol Diethylhexanoate, Ozokerite, Paraffin, Polyethylene, Stearic Acid, Triethoxycaprylylsilane

Other Information

• protect this product from excessive heat and direct sun

image descriptionimage description

BABY PURE AND GENTLE SPF 60 SUNSCREEN 
titanium dioxide - 6.00% zinc oxide - 4.70% stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-333
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide6 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Dimethicone (UNII: 92RU3N3Y1O)  
CANDELILLA WAX (UNII: WL0328HX19)  
Isostearic Acid (UNII: X33R8U0062)  
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)  
CERESIN (UNII: Q1LS2UJO3A)  
Paraffin (UNII: I9O0E3H2ZE)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-333-010.47 g in 1 TUBE; Type 0: Not a Combination Product02/13/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/13/2013
Labeler - CVS (062312574)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(69842-333) , label(69842-333)

Revised: 4/2018
Document Id: 52862ff5-b43d-4151-9f05-7577f0b60e1e
Set id: 372ae3fb-fec0-4c7b-853b-12835c830311
Version: 1
Effective Time: 20180423
 
CVS