OTC Medication Information: Coppertone Sport Suncreen SPF 50

COPPERTONE SPORT SUNCREEN SPF 50- homosalate, octocrylene, octisalate and avobenzone aerosol, spray
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 5%, Octocrylene 5%

Purpose

Sunscreen

Use

■ helps prevent sunburn

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.

■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

■ 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

■ shake well before each use

■ 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

■ store between 20˚ to 25˚C (68˚ to 77˚F)

■ may stain or damage some fabrics or surfaces

Inactive ingredients

SD alcohol 40-B (73.9% v/v), isobutane, neopentyl glycol dipheptanoate, polyester-27, acrylates/octylacrylamide copolymer, dimethicone, fragrance, ascorbyl palmitate

Questions

1-866-288-3330

Coppertone ® Sunscreen Spray

Sport

50

4-in-1 Performance

Stops up to 98% UV Rays

+ Resists Sweat + Heat + Water

Free of Oxybenzone, Octinoxate, PABA & Dyes

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

NET WT 1.6 OZ (45 g)

Sport Spray SPF 50
(click image for full-size original)
COPPERTONE SPORT SUNCREEN SPF 50
avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 5% aerosol, spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-4356
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 5 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
NEOPENTYL GLYCOL DIHEPTANOATE
ASCORBYL PALMITATE
ISOBUTANE
POLYESTER-7
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)
DIMETHICONE
FRAGRANCE FLORAL ORC0902236
Product Characteristics
Color yellow (yellow to pale yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66800-4356-1 45 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: 03/2023 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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