sun x spf 30 thin

sun x spf 30 thin
SPL v6
SPL
SPL Set ID 980388b5-8314-3143-e053-2995a90a7288
Route
topical
Published
Effective Date 2023-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (1 g) homosalate (5 g) octinoxate (7.5 g) octisalate (6 g) oxybenzone
Inactive Ingredients
water dimethyl capramide dimethicone aloe vera leaf .alpha.-tocopherol trolamine propylparaben phenoxyethanol glyceryl monostearate methylparaben ethylparaben butylparaben isobutylparaben alkyl (c12-15) benzoate chamomile calendula officinalis flower peg-100 stearate nasturtium officinale comfrey leaf .alpha.-tocopherol acetate tetrasodium edetate dihydrate fragrance 13576 acrylates crosspolymer-6

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-11-22 Until 2022-11-21

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen Sunscreen

Description

Avobenzone 1.0% Homosalate 5.0% Octinoxate 7.5% Octisalate 5.0% Oxybenzone 6.0%


Medication Information

Warnings

For external use only.

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection.
  • retains SPF after 80 minutes of activity in the water or sweating
  • provides high protection against sunburn.
Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Other Information
  • protect this product from excessive heat and direct sun.

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Description

Avobenzone 1.0% Homosalate 5.0% Octinoxate 7.5% Octisalate 5.0% Oxybenzone 6.0%

Principal Display Panel

101 11

Do Not Use
  • on damaged or broken skin
Directions:
  • apply liberally 15 minutes before sun exposure
  • Reapply:
  • after 80 minutes of swimming or sweating
    • after towel drying, swimming, or
    • at least every 2 hours
  • children under 6 months of age: ask a doctor.
Active Ingredients

Avobenzone 1.0%

Homosalate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 6.0%

Inactive Ingredients:

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, butylparaben, calendula officinalis flower extract, carbomer, chamomile recutita (matricaria) extract, C12-15 alkyl benzoate, dimethicone, dimethyl capramide, ethylparaben, fragrance (parfum), glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale (watercress) extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale (comfrey) leaf extract, tetrasodium EDTA, tocopherol, tocopheryl acetate, triethanolamine, water

Questions and Comments?

Call: 1-877-684-5774

When Using This Product
  • keep out of the eye. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts
Keep Out of the Reach of Children.

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


Structured Label Content

Warnings

For external use only.

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection.
  • retains SPF after 80 minutes of activity in the water or sweating
  • provides high protection against sunburn.
Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Other Information (Other information)
  • protect this product from excessive heat and direct sun.

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Principal Display Panel

101 11 (101-11)

Do Not Use (Do not use)
  • on damaged or broken skin
Directions:
  • apply liberally 15 minutes before sun exposure
  • Reapply:
  • after 80 minutes of swimming or sweating
    • after towel drying, swimming, or
    • at least every 2 hours
  • children under 6 months of age: ask a doctor.
Active Ingredients (Active ingredients)

Avobenzone 1.0%

Homosalate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 6.0%

Inactive Ingredients: (Inactive ingredients:)

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, butylparaben, calendula officinalis flower extract, carbomer, chamomile recutita (matricaria) extract, C12-15 alkyl benzoate, dimethicone, dimethyl capramide, ethylparaben, fragrance (parfum), glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale (watercress) extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale (comfrey) leaf extract, tetrasodium EDTA, tocopherol, tocopheryl acetate, triethanolamine, water

Questions and Comments? (Questions and comments?)

Call: 1-877-684-5774

When Using This Product (When using this product)
  • keep out of the eye. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash or irritation develops and lasts
Keep Out of the Reach of Children. (Keep out of the 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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