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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)
Available from:
Bayer HealthCare LLC.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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
Authorization status:
OTC monograph not final
Authorization number:
11523-7454-1, 11523-7454-2, 11523-7454-3

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

Bayer HealthCare LLC.

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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Coppertone Kids Sport Spray SPF 50 UI 1614350

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 5%

Purpose

Sunscreen

Us es

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 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

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

■ 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 (73.9% v/v), neopentyl glycol diheptanoate, polyester-27,

acrylates/octylacrylamide copolymer, dimethicone, fragrance, ascorbyl palmitate

Questions? 1-866-288-3330

Package display

Improved Formula

Coppertone®

SUNSCREEN SPRAY

kids

SPORT™

Stays on

Strong When

You Sweat

No Dyes, PABA, Oxybenzone

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Pediatrician

Recommended

Brand

NET WT 5.5 OZ (156 g)

COPPERTONE KIDS SPORT SPF 50

avobenzone, homosalate, octisalate, octocrylene spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11523-7454

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Bayer HealthCare LLC.

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

50 mg in 1 g

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

50 mg in 1 g

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

30 mg in 1 g

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

10 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

NEO PENTYL GLYCO L DIHEPTANO ATE (UNII: 5LKW3C543X)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ASCO RBYL PALMITATE (UNII: QN8 3US2B0 N)

Product Characteristics

Color

yello w (clear to pale yello w)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:11523-7454-1

156 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 2/0 1/20 19

0 9 /0 1/20 21

2

NDC:11523-7454-2

19 6 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 2/0 1/20 19

0 9 /0 1/20 21

3

NDC:11523-7454-3

20 8 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 2/0 1/20 19

0 9 /0 1/20 21

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 2/0 1/20 19

0 9 /0 1/20 21

Labeler -

Bayer HealthCare LLC. (112117283)

Revised: 12/2019

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