OTC Medication Information: Coppertone Waterbabies Sunscreen SPF 50

COPPERTONE WATERBABIES SUNSCREEN SPF 50- homosalate, octisalate, octocrylene and avobenzone 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 9%, Octisalate 4.5%, Octocrylene 9%

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, aloe barbadensis leaf juice, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, styrene/acrylates copolymer, butylene glycol,

VP/Eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, fragrance, tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate

Questions?

1-866-288-3330

#1 Pediatrician Recommended Brand

Coppertone Sunscreen Lotion

waterbabies

Fragrance Free

Hypoallergenic

Enriched with Vitamin E

50

Free Of oxybenzone, octinoxate, dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

COPPERTONE WATERBABIES SUNSCREEN SPF 50 avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-4109 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (HOMOSALATE) HOMOSALATE 9 g in 100 g OCTISALATE (OCTISALATE) OCTISALATE 4.5 g in 100 g OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 9 g in 100 g AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g

Inactive Ingredients Ingredient Name Strength WATER ALOE VERA LEAF ALKYL (C12-15) BENZOATE NEOPENTYL GLYCOL DIHEPTANOATE CARBOMER INTERPOLYMER TYPE A (55000 CPS) EICOSYL POVIDONE 1,2-HEXANEDIOL TOCOPHEROL STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) DISODIUM EDTA-COPPER FRAGRANCE CLEAN ORC0600327 POTASSIUM HYDROXIDE SODIUM ASCORBYL PHOSPHATE BUTYLENE GLYCOL HYDROXYACETOPHENONE

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66800-4109-1 30 g in 1 TUBE None 2 NDC:66800-4109-2 59 g in 1 TUBE None 3 NDC:66800-4109-3 88 g in 1 TUBE None 4 NDC:66800-4109-6 177 g in 1 BOTTLE, PLASTIC None 5 NDC:66800-4109-8 237 g in 1 BOTTLE, PLASTIC None 6 NDC:66800-4109-0 296 g in 1 BOTTLE, PLASTIC None 7 NDC:66800-4109-9 315 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