OTC Medication Information: Coppertone Tanning Sunscreen SPF 15

COPPERTONE TANNING SUNSCREEN SPF 15- avobenzone, octisalate, homosalate and octocrylene 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 2%, Homosalate 5%, Octisalate 4.5%, Octocrylene 3%

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

■ 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, 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, tocopherol, beeswax, fragrance, behenyl alcohol, arachidyl glucoside, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate

Questions?

1-866-288-3330

Coppertone ^® Sunscreen Lotion

Tanning

Lightweight & Moisturizing 15

No Dyes, PABA, Oxybenzone

Water Resistant (80 Minutes)

8 FL OZ (237 mL)

COPPERTONE TANNING SUNSCREEN SPF 15 avobenzone 2%, homosalate 5%, octisalate 4.5%, octocrylene 3% lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-4087 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (AVOBENZONE) AVOBENZONE 2 g in 100 g OCTISALATE (OCTISALATE) OCTISALATE 4.5 g in 100 g HOMOSALATE (HOMOSALATE) HOMOSALATE 5 g in 100 g OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 3 g in 100 g

Inactive Ingredients Ingredient Name Strength NEOPENTYL GLYCOL DIHEPTANOATE TOCOPHEROL ARACHIDYL ALCOHOL SYNTHETIC BEESWAX PEG-100 STEARATE ARACHIDYL GLUCOSIDE DISODIUM EDTA-COPPER SODIUM ASCORBYL PHOSPHATE POLYESTER-7 FRAGRANCE FLORAL ORC0902236 POTASSIUM HYDROXIDE GLYCERYL STEARATE SE WATER GLYCERIN PHENOXYETHANOL SILICON DIOXIDE ISODODECANE ETHYLHEXYLGLYCERIN STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) ACRYLATES CROSSPOLYMER-6 ALUMINUM STARCH OCTENYLSUCCINATE DOCOSANOL

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66800-4087-1 237 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 12/20/2021

Labeler — Beiersdorf Inc (001177906)

Revised: 07/2022 Beiersdorf Inc