quality choice d36.000/d36aa

quality choice d36.000/d36aa
SPL v3
SPL
SPL Set ID 6307627a-94e2-47ea-8519-68975716dd6e
Route
topical
Published
Effective Date 2025-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (150 mg) octisalate (50 mg)
Inactive Ingredients
alcohol diisopropyl adipate diethylhexyl 2,6-naphthalate butyloctyl salicylate neopentyl glycol diheptanoate acrylate/isobutyl methacrylate/n-tert-octylacrylamide copolymer (75000 mw) benzyl benzoate butylphenyl methylpropional .beta.-citronellol, (r)- .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-06

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 15% Octisalate 5%


Medication Information

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
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
Purpose

Sunscreen

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

alcohol denat., diisopropyl adipate, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, neopentyl glycol diheptanoate, acrylates/octylacrylamide copolymer, fragrance, benzyl benzoate, butylphenyl methylpropional, citronellol, tocopheryl acetate

Description

Avobenzone 3% Homosalate 15% Octisalate 5%

Principal Display Panel

NDC 83324-157-55

QC ®

QUALITY CHOICE

Sheer Touch

Sunscreen 

Mist

Broad Spectrum

SPF 100

UVA/UVB Sunscreen

Water Resistant (80 Minutes)

Dermatologist Tested

Clean & Lightweight Feel

SPF 100

NET WT 5.5 oz (156g)

Do Not Use
  • on damaged or broken skin
Adverse Reaction

May stain or damage some fabrics or surfaces

100% QC SATISFACTION GUARANTEED

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

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 120ºF.

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

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
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
Purpose

Sunscreen

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

alcohol denat., diisopropyl adipate, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, neopentyl glycol diheptanoate, acrylates/octylacrylamide copolymer, fragrance, benzyl benzoate, butylphenyl methylpropional, citronellol, tocopheryl acetate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 83324-157-55

QC ®

QUALITY CHOICE

Sheer Touch

Sunscreen 

Mist

Broad Spectrum

SPF 100

UVA/UVB Sunscreen

Water Resistant (80 Minutes)

Dermatologist Tested

Clean & Lightweight Feel

SPF 100

NET WT 5.5 oz (156g)

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

May stain or damage some fabrics or surfaces

100% QC SATISFACTION GUARANTEED

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 15%

Octisalate 5%

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 120ºF.

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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