oil free lotion spf 50

oil free lotion spf 50
SPL v4
SPL
SPL Set ID ded1f158-36d1-153f-e053-2995a90ace30
Route
topical
Published
Effective Date 2022-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (8 g) avobenzone (3 g) octisalate (4.5 g) homosalate (10 g)
Inactive Ingredients
water potassium hydroxide aluminum starch octenylsuccinate tocopherol glyceryl stearate se peg-100 stearate disodium edta-copper sodium ascorbyl phosphate arachidyl glucoside polyester-7 ethylhexylglycerin glycerin phenoxyethanol arachidyl alcohol styrene/acrylamide copolymer (mw 500000) synthetic beeswax neopentyl glycol diheptanoate docosanol carbomer interpolymer type a (55000 cps) silicon dioxide isododecane

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2022-04-01

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 8%


Medication Information

Warnings

For external use only

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

■ apply liberally 15 minutes before sun exposure

■ 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

■ may stain or damage some fabrics or surfaces

Inactive Ingredients

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

Description

Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 8%

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 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

Oil Free FACE

50

Won't clog pores or cause breaksouts

Free of oxybenzone, octinoxate, dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

3 FL OZ (88 mL)

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 8%


Structured Label Content

Warnings

For external use only

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

■ apply liberally 15 minutes before sun exposure

■ 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

■ may stain or damage some fabrics or surfaces

Inactive Ingredients (Inactive ingredients)

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

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 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

Oil Free FACE

50

Won't clog pores or cause breaksouts

Free of oxybenzone, octinoxate, dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

3 FL OZ (88 mL)

Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 8%


Advanced Ingredient Data


Raw Label Data

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