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)

Tanning Spray SPF 15
(click image for full-size original)
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

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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