COPPERTONE KIDS SUNSCREEN SPF 50- avobenzone, octocrylene, oxybenzone, octisalate, homosalate stick

Coppertone Kids Sunscreen SPF 50 by

Drug Labeling and Warnings

Coppertone Kids Sunscreen SPF 50 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 ingredients

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

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.

Stop use and ask a doctor if

Stop use and ask a doctor if rash occurs

Keep out of reach of children

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

Directions

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

Inactive ingredients

Inactive ingredients ozokerite, caprylic/capric triglyceride, C12-15 alkyl benzoate, lauryl laurate, behenyl alcohol, bis-PEG-12 dimethicone beeswax, isopropyl myristate, C20-40 alkyl stearate, synthetic beeswax, tocopherol (vitamin E), polyethylene, sorbitan oleate, VP/hexadecane copolymer, aloe barbadensis leaf extract, stearoxy dimethicone, helianthus annuus (sunflower) seed oil

Questions

Questions? 1-866-288-3330

Coppertone Sunscreen Stick Kids .46 label

New Formula

#1

Pediatrician

Recommended

Brand

Coppertone®

SUNSCREEN STICK

KIDS®

Water Resistant

(80 Minutes)

Broad Spectrum

SPF 50

INGREDIENTS AND APPEARANCE

COPPERTONE KIDS SUNSCREEN SPF 50 
avobenzone, octocrylene, oxybenzone, octisalate, homosalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7434
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	134.2 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	26.8 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	89.5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	44.7 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	53.7 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
LAURYL LAURATE (UNII: GPW77G0937)

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: 11523-7434-1	13 g in 1 BLISTER PACK; Type 0: Not a Combination Product	11/01/2017	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2017	01/01/2021

Labeler - Bayer HealthCare LLC. (112117283)