Tanning Lotion Spf 8

Tanning Lotion Spf 8
SPL v7
SPL
SPL Set ID d370094c-3373-594b-e053-2a95a90a114a
Route
TOPICAL
Published
Effective Date 2021-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (3 g) Avobenzone (2 g) Octisalate (4.5 g) Homosalate (5 g)
Inactive Ingredients
Aluminum Starch Octenylsuccinate Potassium Hydroxide Water Glycerin Fragrance Floral Orc0902236 Isododecane Ethylhexylglycerin Phenoxyethanol Polyester-7 Docosanol Styrene/acrylamide Copolymer (mw 500000) Silicon Dioxide Acrylates Crosspolymer-6 Arachidyl Glucoside Disodium Edta-copper Sodium Ascorbyl Phosphate Peg-100 Stearate Arachidyl Alcohol Neopentyl Glycol Diheptanoate Glyceryl Stearate Se Synthetic Beeswax

Identifiers & Packaging

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

Description

Avobenzone 2%, Homosalate 5%, Octisalate 4.5%, Octocrylene 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2%, Homosalate 5%, Octisalate 4.5%, Octocrylene 3%

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 Lotion

Tanning

Lightweight & Moisturizing 8

No Dyes, PABA, Oxybenzone

Water Resistant (80 Minutes)

Broad Spectrum SPF 8

8 FL OZ (237 mL)

Warnings

Skin Cancer/Skin Aging Alert:Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Questions

1-866-288-3330

Directions

■ apply liberally 15 minutes before sun exposure

■ reapply:

■ after 80 minutes of swimming or sweating

■ immediately after towel drying

■ at least every 2 hours

■ children under 6 months: Ask a doctor

Other Information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Active Ingredients

Avobenzone 2%, Homosalate 5%, Octisalate 4.5%, Octocrylene 3%

Inactive Ingredients

water, aluminum starch octenylsuccinate, glycerin, silica, phenoxyethanol, isododecane, ethylhexylglycerin, polyester-27, styrene/acrylates copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, arachidyl alcohol, neopentyl glycol diheptanoate, glyceryl stearate, PEG-100 stearate, beeswax, fragrance, behenyl alcohol, arachidyl glucoside, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate


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 Lotion

Tanning

Lightweight & Moisturizing 8

No Dyes, PABA, Oxybenzone

Water Resistant (80 Minutes)

Broad Spectrum SPF 8

8 FL OZ (237 mL)

Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert:Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Questions

1-866-288-3330

Directions

■ apply liberally 15 minutes before sun exposure

■ reapply:

■ after 80 minutes of swimming or sweating

■ immediately after towel drying

■ at least every 2 hours

■ children under 6 months: Ask a doctor

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 2%, Homosalate 5%, Octisalate 4.5%, Octocrylene 3%

Inactive Ingredients (Inactive ingredients)

water, aluminum starch octenylsuccinate, glycerin, silica, phenoxyethanol, isododecane, ethylhexylglycerin, polyester-27, styrene/acrylates copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, arachidyl alcohol, neopentyl glycol diheptanoate, glyceryl stearate, PEG-100 stearate, beeswax, fragrance, behenyl alcohol, arachidyl glucoside, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate


Advanced Ingredient Data


Raw Label Data

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