limited edition spray spf 50

limited edition spray spf 50
SPL v5
SPL
SPL Set ID ccbf7795-e153-1a43-e053-2a95a90ad4b6
Route
topical
Published
Effective Date 2021-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (5 g) avobenzone (3 g) homosalate (10 g) octocrylene
Inactive Ingredients
fragrance floral orc0902236 alcohol neopentyl glycol diheptanoate polyester-7 acrylates crosspolymer-6 dimethicone ascorbyl palmitate isobutane

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2020-11-04

Purpose

Sunscreen

Description

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


Medication Information

Warnings

For external use only

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

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

Purpose

Sunscreen

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

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

Inactive Ingredients

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

Description

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

Questions?

1-866-288-3330

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

Limited Edition

Coppertone ®Sunscreen Spray 50

Protects against damaging UVA/UVB rays

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

NET WT 1.6 OZ (45 g)

Active Ingredients

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


Structured Label Content

Warnings

For external use only

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

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

Purpose

Sunscreen

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

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

Inactive Ingredients (Inactive ingredients)

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

Questions?

1-866-288-3330

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)

Limited Edition

Coppertone ®Sunscreen Spray 50

Protects against damaging UVA/UVB rays

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

NET WT 1.6 OZ (45 g)

Active Ingredients (Active ingredients)

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


Advanced Ingredient Data


Raw Label Data

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