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

Baby Pure and Gentle SPF 60 Sunscreen by

Drug Labeling and Warnings

Baby Pure and Gentle SPF 60 Sunscreen by is a Otc medication manufactured, distributed, or labeled by CVS, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                     Purpose

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

PURPOSE

Uses

 helps prevent sunburn

WarningsFor 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	6 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-333-01	0.47 g in 1 TUBE; Type 0: Not a Combination Product	02/13/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/13/2013

Labeler - CVS (062312574)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(69842-333) , label(69842-333)