Kids Spray Spf 50

Kids Spray Spf 50
SPL v6
SPL
SPL Set ID cbf9a785-f218-76fb-e053-2995a90a8e03
Route
TOPICAL
Published
Effective Date 2021-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 g) Octisalate (5 g) Octocrylene (3 g) Avobenzone
Inactive Ingredients
Dimethicone Isobutane Alcohol Neopentyl Glycol Diheptanoate Polyester-7 Fragrance Floral Orc0902236 Acrylates Crosspolymer-6

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-01

Description

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

Use

■ helps prevent sunburn

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor ifrash occurs

Section 50567-7

When using this product

■ keep away from face to avoid breathing it

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

■ use only as directed. Intentional misuse by deliberately concentrating and inhaling

the contents can be harmful or fatal.

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

Section 50570-1

Do not useon damaged or broken skin



Section 51945-4

Coppertone ® Sunscreen Spray

#1 Pediatrician Recommended Brand

kids

50

Stays on Strong Evien in Water

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Net Wt 5.0 oz (156 g)

Warnings

For external use only

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

Directions

■ shake well before each use

■ 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

Questions?

1-866-288-3330

Other Information

■ protect this product from excessive heat and direct sun

■ store between 20° to 25°C (68° to 77°F)

■ may stain or damage some fabrics or surfaces

Active Ingredients

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

Inactive Ingredients

SD alcohol 40-B (42.8% v/v), isobutane, neopentyl glycol diheptanoate, polyester-27, acrylates/octylacrylamide copolymer, dimethicone, fragrance


Structured Label Content

Use

■ helps prevent sunburn

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor ifrash occurs

Section 50567-7 (50567-7)

When using this product

■ keep away from face to avoid breathing it

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

■ use only as directed. Intentional misuse by deliberately concentrating and inhaling

the contents can be harmful or fatal.

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

Section 50570-1 (50570-1)

Do not useon damaged or broken skin



Section 51945-4 (51945-4)

Coppertone ® Sunscreen Spray

#1 Pediatrician Recommended Brand

kids

50

Stays on Strong Evien in Water

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Net Wt 5.0 oz (156 g)

Purpose

Sunscreen

Warnings

For external use only

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

Directions

■ shake well before each use

■ 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

Questions?

1-866-288-3330

Other Information (Other information)

■ protect this product from excessive heat and direct sun

■ store between 20° to 25°C (68° to 77°F)

■ may stain or damage some fabrics or surfaces

Active Ingredients (Active ingredients)

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

Inactive Ingredients (Inactive ingredients)

SD alcohol 40-B (42.8% v/v), isobutane, neopentyl glycol diheptanoate, polyester-27, acrylates/octylacrylamide copolymer, dimethicone, fragrance


Advanced Ingredient Data


Raw Label Data

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