Quality Choice D46.000/d46aa

Quality Choice D46.000/d46aa
SPL v3
SPL
SPL Set ID 87811c86-19d2-4179-8d22-2aeb4680ff57
Route
TOPICAL
Published
Effective Date 2025-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (150 mg) Octisalate (50 mg) Avobenzone (30 mg)
Inactive Ingredients
Alcohol Diethylhexyl 2,6-naphthalate Diisopropyl Adipate Neopentyl Glycol Diheptanoate Butyloctyl Salicylate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (40000 Mw) .alpha.-amylcinnamaldehyde Hydroxycitronellal Linalool, (+/-)- .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-19

Description

Avobenzone 3% Homosalate 15% Octisalate 5%

Purpose

Sunscreen


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • 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
Purpose

Sunscreen

Dosage and Administration

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

■ apply to all skin exposed to the sun

■ 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 and avoid inhalation

■ 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-sleeved shirts, pants, hats and sunglasses

■ children under 6 months of age: Ask a doctor

Description

Avobenzone 3% Homosalate 15% Octisalate 5%

Claims

May stain or damage some fabrics or surfaces

Flammable

Flammable: keep away from fire or flame.

  • After application, wait until product dries before approaching a source of heat or flame, or before smoking
Disclaimer

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone Sport ® Sunscreen Spray Broad Spectrum SPF 70.

Do Not Use
  • on damaged or broken skin
Adverse Reaction

100% QC

SATISFACTION GUARANTEED

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Other Information
  • protect the product in this container from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Inactive Ingredients

alcohol denat., diethylhexyl 2,6-naphthalate, diisopropyl adipate, neopentyl glycol diheptanoate, butyloctyl salicylate, acrylates/octylacrylamide copolymer, fragrance, amyl cinnamal, hydroxycitronellal, linalool, tocopheryl acetate

Principal Display Panel

NDC 83324-319-55

QC ®

QUALITY CHOICE

*Compare to COPPERTONE SPORT ®

Continuous Spray

Sport 

Sunscreen

Broad Spectrum

SPF 70

UVA/UVB Sunscreen

Water Resistant (80 Minutes)

Continuous Spray From Any Angle

Sweat-Resistant Formula

SPF 70

NET WT 5.5 OZ (156 g)

When Using This Product
  • keep out of eyes. Rinse with water to remove.
  • contents under pressure.  Do not puncture or incinerate.  Do not store at temperature above 120°F.
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If 
  • rash occurs

Structured Label Content

Claims

May stain or damage some fabrics or surfaces

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)

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

■ apply to all skin exposed to the sun

■ 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 and avoid inhalation

■ 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-sleeved shirts, pants, hats and sunglasses

■ children under 6 months of age: Ask a doctor

Warnings and Precautions (34071-1)

For external use only

Purpose

Sunscreen

Flammable

Flammable: keep away from fire or flame.

  • After application, wait until product dries before approaching a source of heat or flame, or before smoking
Disclaimer

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone Sport ® Sunscreen Spray Broad Spectrum SPF 70.

Do Not Use (Do not use)
  • on damaged or broken skin
Adverse Reaction (ADVERSE REACTION)

100% QC

SATISFACTION GUARANTEED

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Inactive Ingredients (Inactive ingredients)

alcohol denat., diethylhexyl 2,6-naphthalate, diisopropyl adipate, neopentyl glycol diheptanoate, butyloctyl salicylate, acrylates/octylacrylamide copolymer, fragrance, amyl cinnamal, hydroxycitronellal, linalool, tocopheryl acetate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 83324-319-55

QC ®

QUALITY CHOICE

*Compare to COPPERTONE SPORT ®

Continuous Spray

Sport 

Sunscreen

Broad Spectrum

SPF 70

UVA/UVB Sunscreen

Water Resistant (80 Minutes)

Continuous Spray From Any Angle

Sweat-Resistant Formula

SPF 70

NET WT 5.5 OZ (156 g)

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
  • contents under pressure.  Do not puncture or incinerate.  Do not store at temperature above 120°F.
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )
  • rash occurs

Advanced Ingredient Data


Raw Label Data

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