COPPERTONE KIDS SPF 50- avobenzone, homosalate, octisalate, octocrylene aerosol, spray

Coppertone Kids by

Drug Labeling and Warnings

Coppertone Kids 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 10%, Octisalate 5%,

Octocrylene 5%

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

Flammable: Do not use near heat, flame, or while smoking

Do not use on damaged or broken skin

When using this product

When using this product

■ keep out of eyes. Rinse with water to remove.

■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F.

Stop use and ask a doctor if

Stop useand 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.

Directions

Directions

■ apply liberally 15 minutes before sun exposure

■ do not spray directly on face. Spray into hands and apply to face

■ use in well-ventilated areas

■ 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

■ avoid long-term storage above 40˚C (104˚F)

■ may stain or damage some fabrics or surfaces

INACTIVE INGREDIENT

Inactive ingredients SD alcohol 40-B (73.8% v/v), neopentyl glycol diheptanoate, polyester-27, acrylates/octylacrylamide copolymer, dimethicone, fragrance, ascorbyl palmitate

QUESTIONS

Questions? 1-866-288-3330

Can label 5.5 oz.

Coppetone®

Sunscreen Spray

kids®

Stays on Strong

When Kids Play 50

No Dyes, PABA, Oxybenzone

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

#1

Pediatrician

Recommended

Brand

Dist. by:

Bayer HealthCare LLC

Whippany, NJ 07981

INGREDIENTS AND APPEARANCE

COPPERTONE KIDS  SPF 50
avobenzone, homosalate, octisalate, octocrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7438
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

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: 11523-7438-1	156 g in 1 CAN; Type 0: Not a Combination Product	02/01/2019	05/01/2021
2	NDC: 11523-7438-2	196 g in 1 CAN; Type 0: Not a Combination Product	02/01/2019	05/01/2021
3	NDC: 11523-7438-3	208 g in 1 CAN; Type 0: Not a Combination Product	02/01/2019	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2019	05/01/2021

Labeler - Bayer HealthCare LLC. (112117283)