OTC Medication Information: Coppertone Sunscreen SPF 50

COPPERTONE SUNSCREEN SPF 50- octisalate, octocrylene, avobenzone and homosalate lotion
Beiersdorf Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients

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

Purpose

Sunscreen

Use

■ helps prevent sunburn

Warnings

For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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, fragrance, disodium EDTA, sodium ascorbyl phosphate

Questions?

1-866-288-3330

Coppertone® Suncreen Lotion

Sport 50

4-IN-1 Performance

Stops up to 98% UV Rays

+Resists

Sweat+Heat+Water

Free of Oxybenzone, Octinoxate, PABA, Phthalates & Dyes

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

COPPERTONE SUNSCREEN SPF 50 avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 8% lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-4107 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (OCTISALATE) OCTISALATE 4.5 g in 100 g OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 8 g in 100 g AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 g

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE DISODIUM EDTA-COPPER PEG-20 STEARATE STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) ARACHIDYL ALCOHOL ALUMINUM STARCH OCTENYLSUCCINATE NEOPENTYL GLYCOL DIHEPTANOATE DOCOSANOL ARACHIDYL GLUCOSIDE ETHYLHEXYLGLYCERIN GLYCERYL STEARATE SE GLYCERIN SYNTHETIC BEESWAX PHENOXYETHANOL POTASSIUM HYDROXIDE TOCOPHEROL CARBOMER INTERPOLYMER TYPE A (55000 CPS) WATER FRAGRANCE FLORAL ORC0902236 POLYESTER-7 ISODODECANE SODIUM ASCORBYL PHOSPHATE

Product Characteristics Color white (white to off-white) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66800-4107-3 89 g in 1 TUBE None 2 NDC:66800-4107-7 207 g in 1 BOTTLE, PLASTIC None 3 NDC:66800-4107-8 259 g in 1 BOTTLE, PLASTIC None 4 NDC:66800-4107-9 269 g in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/02/2020

Labeler — Beiersdorf Inc (001177906)

Revised: 07/2022 Beiersdorf Inc