OTC Medication Information: Coppertone Tanning Sunscreen SPF 8

COPPERTONE TANNING SUNSCREEN SPF 8- octocrylene, avobenzone, octisalate 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 2%, Homosalate 5%, Octisalate 4.5%, Octocrylene 3%

Purpose

Sunscreen

Use

■ helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 8

No Dyes, PABA, Oxybenzone

Water Resistant (80 Minutes)

Broad Spectrum SPF 8

8 FL OZ (237 mL)

Tanning Lotion SPF8
(click image for full-size original)
COPPERTONE TANNING SUNSCREEN SPF 8
avobenzone 2%, homosalate 5%, octisalate 4.5%, octocrylene 3% lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-4086
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 3 g in 100 g
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
Inactive Ingredients
Ingredient Name Strength
FRAGRANCE FLORAL ORC0902236
ISODODECANE
ETHYLHEXYLGLYCERIN
ALUMINUM STARCH OCTENYLSUCCINATE
POTASSIUM HYDROXIDE
WATER
GLYCERIN
PHENOXYETHANOL
POLYESTER-7
DOCOSANOL
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)
SILICON DIOXIDE
ACRYLATES CROSSPOLYMER-6
TOCOPHEROL
ARACHIDYL GLUCOSIDE
DISODIUM EDTA-COPPER
SODIUM ASCORBYL PHOSPHATE
PEG-100 STEARATE
ARACHIDYL ALCOHOL
NEOPENTYL GLYCOL DIHEPTANOATE
GLYCERYL STEARATE SE
SYNTHETIC BEESWAX
Product Characteristics
Color white (White to Off-White) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66800-4086-1 237 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 11/03/2020
Labeler — Beiersdorf Inc (001177906)
Establishment
Name Address ID/FEI Operations
Beiersdorf Manufacturing México, S.A. de C.V. 812293032 manufacture (66800-4086)

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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