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

Sport 50
(click image for full-size original)
Sport 50 rear
(click image for full-size original)
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

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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