COPPERTONE KIDS SPORT SPF 100- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Coppertone Kids Sport SPF 100 by

Drug Labeling and Warnings

Coppertone Kids Sport SPF 100 by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%,

Octocrylene 10%, Oxybenzone 6%

PURPOSE

Purpose

Sunscreen

Uses

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

Warnings
For external use only

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

DOSAGE & ADMINISTRATION

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 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-sleeve shirts, pants, hats, and sunglasses

■ children under 6 months: Ask a doctor

Other information

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

INACTIVE INGREDIENT

Inactive ingredients water, butyloctyl salicylate, styrene/acrylates copolymer, butylene glycol, benzyl alchohol, bis-stearyl ethylenediamine/neopentyl glycol/stearyl hydrogenated dimer dilinoleate copolymer, tocopherol (vitamin E), diethylhexyl syringylidenamalonate, retinyl palmitate (vitamin A palmitate), sodium ascorbyl phosphate, triethanolamine, chlorphenesin, acrylates/C10-30 alkyl acrylate crosspolymer, oleth-3, fragrance, disodium EDTA

QUESTIONS

Questions? 1-866-288-3330

Package label 4 oz.

New!

Coppertone®

SUNSCREEN LOTION

kids

SPORT™

Stays on Strong

When You Sweat 100

No Dyes, PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 100

#1

Pediatrician

Recommended

Brand

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

COPPERTONE KIDS SPORT SPF 100 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7467
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.54 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50.9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	101.8 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	61.08 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	152.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
TROLAMINE (UNII: 9O3K93S3TK)
CHLORPHENESIN (UNII: I670DAL4SZ)
OLETH-3 (UNII: BQZ26235UC)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)

Product Characteristics
Color	white (off white to light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7467-1	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018	09/01/2021

Labeler - Bayer HealthCare LLC. (112117283)