COPPERTONE KIDS SPORT SUNSCREEN SPF 100- avobenzone 3%, homosalate 15%, octinoxate 2% octisalate 5%, octocrylene 10%, oxybenzone 6% spray

Coppertone Kids Sport Sunscreen SPF 100 by

Drug Labeling and Warnings

Coppertone Kids Sport Sunscreen SPF 100 by is a Otc medication manufactured, distributed, or labeled by Beiersdorf Inc, Formulated Solutions Cleveland, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 15%, Octinoxate 2%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

Purpose

Sunscreen

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

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
■ keep away from face to avoid breathing it

■ 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 rash occurs

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

Directions

■ spray liberally and spread evenly by hand 15 minutes before sun exposure

■ hold container 4 to 6 inches from the skin to apply

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

■ do not apply in windy conditions

■ use in a well-ventilated area

■ 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

■ 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 ingredients

SD alcohol 40-B (53.2% v/v), acrylates/octylacrylamide copolymer, ethylhexyl methoxycrylene, isohexadecane, isododecane, glycerin, C13-15 alkane, PEG-2 cocamine, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), fragrance

Questions

1-866-288-3330

Principal Display Panel

#1 Pediatrician Recommended Brand

Coppertone ® Sunscreen Spray

kids Sport

High Performance for Active Play 100

Free of PABA, parabens and dyes

Water Resistant (80 Minutes)

Broad Specturm SPF 100

Net Wt 5.5 OZ (156 g)

INGREDIENTS AND APPEARANCE

COPPERTONE KIDS SPORT SUNSCREEN SPF 100 
avobenzone 3%, homosalate 15%, octinoxate 2% octisalate 5%, octocrylene 10%, oxybenzone 6% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-2495
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOHEXADECANE (UNII: 918X1OUF1E)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
C13-15 ALKANE (UNII: 114P5I43UJ)
PEG-3 COCAMINE (UNII: KTM00873VC)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
TOCOPHEROL (UNII: R0ZB2556P8)
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
ALCOHOL (UNII: 3K9958V90M)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
OCTYL ACRYLATE (UNII: EJN94319DN)

Product Characteristics
Color	yellow ((Clear to Pale Yellow))	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66800-2495-5	156 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/08/2021

Labeler - Beiersdorf Inc (001177906)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions Cleveland, LLC		118876008	manufacture(66800-2495)