COPPERTONE KIDS SPF 50- octinoxate, octisalate and zinc oxide lotion
Schering-Plough HealthCare Products, Inc.

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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Drug Facts

Active ingredients

Octinoxate 7.5%, Octisalate 5%, Zinc Oxide 14.5%

Purpose

Sunscreen

Uses

screens out the sun's burning rays to help prevent sunburn
provides protection from UVA rays that may contribute to skin damage and premature aging of the skin
higher SPF gives more sunburn protection
retains SPF after 80 minutes of activity in the water or sweating

Warnings

For external use only.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

shake well before use
adults and children 6 months of age and older: apply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Reapply as needed or after towel drying, swimming, perspiring, or vigorous activity.
children under 6 months of age: ask a doctor

Inactive ingredients

Water, Propylene Glycol, C12-15 Alkyl Benzoate, Neopentyl Glycol Diheptanoate, Cyclopentasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, PEG-12 Dimethicone Crosspolymer, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Extract, Ethylhexyl Palmitate, Diazolidinyl Urea, Methylparaben, Propylparaben, Sodium Chloride

PRINCIPAL DISPLAY PANEL - 237 mL bottle

Coppertone®

KIDS®
SUNSCREEN LOTION

Pure &
Simple

tear free

OIL, FRAGRANCE
& DYE FREE

50
SPF

Broad Spectrum
UVA/UVB Protection
Waterproof

8 FL OZ (237 mL)

COPPERTONE KIDS SPF 50
octinoxate, octisalate, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-7301
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (Octinoxate)	Octinoxate	85.2 mg in 1 mL
Octisalate (Octisalate)	Octisalate	56.8 mg in 1 mL
Zinc Oxide (Zinc)	Zinc Oxide	164.72 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water
Propylene Glycol
Aloe Vera Leaf
Ethylhexyl Palmitate
DiazolidinylUrea
Methylparaben
Propylparaben
Sodium Chloride

Product Characteristics
Color	WHITE (white to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:11523-7301-1	237 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/21/1999

Labeler - Schering-Plough HealthCare Products, Inc. (039137567)

Revised: 12/2009

Document Id: ced3f010-67eb-4eb4-92c8-9503fa1d1fb2

Set id: 843715b1-1708-4713-9b37-1dbee1d03610

Version: 1

Effective Time: 20091208

Schering-Plough HealthCare Products, Inc.