Complete Spray Spf 30

Complete Spray Spf 30
SPL v2
SPL
SPL Set ID d4757d99-bac6-48fb-e053-2a95a90ab1bf
Route
TOPICAL
Published
Effective Date 2024-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Octocrylene (7 g) Homosalate (8 g) Octisalate (4.5 g)
Inactive Ingredients
Neopentyl Glycol Diheptanoate Polyester-7 Alcohol Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Fragrance Fresh Citrus Floral Orc1501495 Ascorbyl Palmitate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-03

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

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

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.

■ 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

Complete 30

Proven UVA/UVB Protection

+ Moisturizes All Day

+ Feels Lightweight

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 30

Warnings

For external use only

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

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

Questions?

1-866-288-3330

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

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

Inactive Ingredients

SD alcohol 40-B (73.4% v/v), neopentyl glycol diheptanoate, polyester-27, acrylates/octylacrylamide copolymer, dimethicone, fragrance, ascorbyl palmitate


Structured Label Content

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

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.

■ 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

Complete 30

Proven UVA/UVB Protection

+ Moisturizes All Day

+ Feels Lightweight

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 30

Purpose

Sunscreen

Warnings

For external use only

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

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

Questions?

1-866-288-3330

Other Information (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

Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

Inactive Ingredients (Inactive ingredients)

SD alcohol 40-B (73.4% v/v), neopentyl glycol diheptanoate, polyester-27, acrylates/octylacrylamide copolymer, dimethicone, fragrance, ascorbyl palmitate


Advanced Ingredient Data


Raw Label Data

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