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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Available from:

CVS

INN (International Name):

Titanium Dioxide

Composition:

Titanium Dioxide 6 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Titanium Dioxide - 6.00%          Sunscreen  Zinc Oxide - 4.70%                    Sunscreen  helps prevent sunburn 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

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
US ES
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
BABY PURE AND GENTLE SPF 60 SUNSCREEN
titanium dioxide - 6.00% zinc oxide - 4 .70% stick
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 8 42-333
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
TITA NIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9
V2JP)
Titanium Dio xide