Protect & Tan Spf 45

Protect & Tan Spf 45
SPL v5
SPL
SPL Set ID d39a009d-1f33-88bb-e053-2a95a90a03a0
Route
TOPICAL
Published
Effective Date 2021-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 g) Octisalate (5 g) Avobenzone (3 g) Homosalate (15 g)
Inactive Ingredients
Caramel Allyl Methacrylate Water L-erythrulose Docosanol Dihydroxyacetone Styrene/acrylamide Copolymer (mw 500000) Hydroxyacetophenone Sodium Stearoyl Glutamate Fragrance Fresh Citrus Floral Orc1501495 Arachidyl Alcohol Butylene Glycol Arachidyl Glucoside Butyloctyl Salicylate Neopentyl Glycol Diheptanoate Pentylene Glycol Tocopherol 1,2-hexanediol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-03

Description

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

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 productkeep out of eyes. Rinse with water to remove.

Section 50570-1

Do not useon damaged or broken skin

Section 51945-4

Coppertone® Sunscreen + Self Tanner

Glow

Protect & Tan 45

UVA/UVB Protection + Gradual Tanner

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 45

5 FL OZ (148 mL)

Warnings

For external use only

Directions

■ apply liberally 15 minutes before sun exposure

■ reapply at least every 2 hours

■ use a water resistant sunscreen if swimming or sweating

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

■ may stain or damage some fabrics or surfaces

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Inactive Ingredients

water, butyloctyl salicylate, neopentyl glycol diheptanoate, butylene glycol, styrene/acrylates copolymer, arachidyl alcohol, behenyl alcohol, dihydroxyacetone, acrylates/C12-22 alkyl methacrylate copolymer, 1,2-hexanediol, sodium stearoyl glutamate, arachidyl glucoside, erythrulose, hydroxyacetophenone, tocopherol, fragrance, pentylene glycol, caramel


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 productkeep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not useon damaged or broken skin

Section 51945-4 (51945-4)

Coppertone® Sunscreen + Self Tanner

Glow

Protect & Tan 45

UVA/UVB Protection + Gradual Tanner

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 45

5 FL OZ (148 mL)

Purpose

Sunscreen

Warnings

For external use only

Directions

■ apply liberally 15 minutes before sun exposure

■ reapply at least every 2 hours

■ use a water resistant sunscreen if swimming or sweating

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

■ may stain or damage some fabrics or surfaces

Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

water, butyloctyl salicylate, neopentyl glycol diheptanoate, butylene glycol, styrene/acrylates copolymer, arachidyl alcohol, behenyl alcohol, dihydroxyacetone, acrylates/C12-22 alkyl methacrylate copolymer, 1,2-hexanediol, sodium stearoyl glutamate, arachidyl glucoside, erythrulose, hydroxyacetophenone, tocopherol, fragrance, pentylene glycol, caramel


Advanced Ingredient Data


Raw Label Data

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