Every Tone Lotion Spf 50

Every Tone Lotion Spf 50
SPL v5
SPL
SPL Set ID f3e3f4c6-2cb9-7b17-e053-2a95a90a3854
Route
TOPICAL
Published
Effective Date 2023-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octocrylene (9 g) Homosalate (4.5 g) Octisalate
Inactive Ingredients
Ammonium Acryloyldimethyltaurate/beheneth-25 Methacrylate Crosspolymer (52000 Mpa.s) Diisopropyl Adipate Dimethicone Polyamide-8 (4500 Mw) Isododecane Tocopherol Styrene/acrylamide Copolymer (mw 500000) Arachidyl Glucoside Alcohol Glycereth-26 Ethylhexyl Methoxycrylene Butylene Glycol Xanthan Gum Docosanol Sodium Ascorbyl Phosphate Water Butyloctyl Salicylate Diethylhexyl Carbonate Hydroxyacetophenone Disodium Edta-copper Glycerin 1,2-hexanediol Arachidyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%

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

Advised by Dermatologists for Skin of Color

Every Tone

Blends Clear On All Skin Tones

50

No White Resdiue

Lightweight & Won't Clog Pores

with nourishing Vitamin E

Free of Oxybenzone, Octinoxate, PABA & Phthalates

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Warnings

For external use only

Directions

■ shake well before use

■ 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

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 9%, Octisalate 4.5%, Octocrylene 9%

Inactive Ingredients

water, alcohol denat., butyloctyl salicylate, diethylhexyl carbonate, glycereth-26, styrene/acrylates copolymer, butylene glycol, diisopropyl adipate, dimethicone, polyamide-8, isododecane, glycerin, tocopherol (Vitamin E), hydroxyacetophenone, 1,2-hexanediol, ammonium acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer, ethylhexyl methoxycrylene, arachidyl alcohol, xanthan gum, behenyl alcohol, arachidyl glucoside, sodium ascorbyl phosphate, disodium EDTA


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

Advised by Dermatologists for Skin of Color

Every Tone

Blends Clear On All Skin Tones

50

No White Resdiue

Lightweight & Won't Clog Pores

with nourishing Vitamin E

Free of Oxybenzone, Octinoxate, PABA & Phthalates

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Purpose

Sunscreen

Warnings

For external use only

Directions

■ shake well before use

■ 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

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 9%, Octisalate 4.5%, Octocrylene 9%

Inactive Ingredients (Inactive ingredients)

water, alcohol denat., butyloctyl salicylate, diethylhexyl carbonate, glycereth-26, styrene/acrylates copolymer, butylene glycol, diisopropyl adipate, dimethicone, polyamide-8, isododecane, glycerin, tocopherol (Vitamin E), hydroxyacetophenone, 1,2-hexanediol, ammonium acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer, ethylhexyl methoxycrylene, arachidyl alcohol, xanthan gum, behenyl alcohol, arachidyl glucoside, sodium ascorbyl phosphate, disodium EDTA


Advanced Ingredient Data


Raw Label Data

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