Quality Choice D42.000/d42aa

Quality Choice D42.000/d42aa
SPL v5
SPL
SPL Set ID d7215a32-00a9-4b70-8597-8ea91f546c1e
Route
TOPICAL
Published
Effective Date 2025-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (120 mg) Octisalate (50 mg)
Inactive Ingredients
Alcohol Diethylhexyl 2,6-naphthalate Diisopropyl Adipate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (40000 Mw) Butyloctyl Salicylate Neopentyl Glycol Diheptanoate .alpha.-amylcinnamaldehyde Hydroxycitronellal Linalool, (+/-)- .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-08

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

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
Section 51727-6

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

Warnings

For external use only

Flammable: Keep away from fire or flame.

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

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Sunscreen Spray Kids Broad Spectrum SPF 50.

Do Not Use
  • on damaged or broken skin
Adverse Reaction

100% QC SATISFACTION GUARANTEED

Dstributed 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 12%

Octisalate 5%

Principal Display Panel

NDC 83324-184-05

QC ®

Quality

Choice

*Compare to COPPERTONE ®KIDS

Kids

Sunscreen

Spray

Broad Spectrum SPF 50

UVA/UVB Sunscreen

Water Resistant (80 Minutes)

Continuous Spray From Any Angle

SPF 50

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.
Stop Use and Ask A Doctor If
  • rash occurs
Keep Out of Reach of Children.

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


Structured Label Content

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
Section 51727-6 (51727-6)

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

Purpose

Sunscreen

Warnings

For external use only

Flammable: Keep away from fire or flame.

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

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Sunscreen Spray Kids Broad Spectrum SPF 50.

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

100% QC SATISFACTION GUARANTEED

Dstributed 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 (Active ingredients)

Avobenzone 3%

Homosalate 12%

Octisalate 5%

Principal Display Panel (Principal display panel)

NDC 83324-184-05

QC ®

Quality

Choice

*Compare to COPPERTONE ®KIDS

Kids

Sunscreen

Spray

Broad Spectrum SPF 50

UVA/UVB Sunscreen

Water Resistant (80 Minutes)

Continuous Spray From Any Angle

SPF 50

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


Advanced Ingredient Data


Raw Label Data

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