OTC Medication Information: Coppertone Sport Sunscreen SPF 70

COPPERTONE SPORT SUNSCREEN SPF 70- homosalate, octisalate, octocrylene, oxybenzone and avobenzone aerosol
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 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

Purpose

Sunscreen

Uses

■ helps prevent sunburn

■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only


Flammable: Do not use near heat, flame, or while smoking


Do not use on damaged or broken skin


When using this product
■ keep away from face to avoid breathing it

■ keep out of eyes. Rinse with water to remove.

■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F.

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

■ spray liberally and spread evenly by hand 15 minutes before sun exposure

■ hold container 4 to 6 inches from the skin to apply

■ do not spray directly into face. Spray on hands then apply to face.

■ do not apply in windy conditions

■ use in a well-ventilated area

■ 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

■ avoid long-term storage above 40˚C (104˚F)

■ may stain or damage some fabrics or surfaces

Inactive ingredients

SD alcohol 40-B (63.5% v/v), acrylates/octylacrylamide copolymer, glycerin, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), fragrance, retinyl palmitate (vitamin A palmitate), caprylic/capric triglyceride

Questions

1-866-288-3330

Coppertone ® Sunscreen Spray

Sport™ 70

Stays on Strong When You Sweat

No Dyes, PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 70

Net Wt 5.5 OZ (156 g)

Sport Spray SPF 70 BOV
(click image for full-size original)
COPPERTONE SPORT SUNSCREEN SPF 70
avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10%, oxybenzone 6% aerosol
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-2391
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 15 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 6 g in 100 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)
GLYCERIN
TOCOPHEROL
VITAMIN A PALMITATE
ALCOHOL
DIETHYLHEXYL SYRINGYLIDENEMALONATE
FRAGRANCE FLORAL ORC0902236
MEDIUM-CHAIN TRIGLYCERIDES
Product Characteristics
Color yellow (Yellow to Pale Yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66800-2391-5 156 g in 1 CAN 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)

Revised: 09/2021 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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