Allies Of Skin Sunless Tan Spf-50 Daily Self-tanner

Allies Of Skin Sunless Tan Spf-50 Daily Self-tanner
SPL v2
SPL
SPL Set ID 4d58de8e-875b-4b77-b0ef-b9d760aaced8
Route
TOPICAL
Published
Effective Date 2025-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (73 mg) Octocrylene (75 mg) Ethylhexyl Salicylate (50 mg)
Inactive Ingredients
Aloe Vera Leaf Ascorbic Acid Levomenol Butyloctyl Salicylate Alkyl (c12-15) Benzoate C9-12 Alkane Green Tea Leaf Medium-chain Triglycerides Centella Asiatica Triterpenoids Chamomile Citric Acid Monohydrate Daucus Carota Subsp. Sativus Seed Dihydroxyacetone Dimethicone/bis-isobutyl Ppg-20 Crosspolymer Dodecane Ethylhexylglycerin Glycerin Glyceryl Stearate Citrate Glyceryl Stearate Se Glycyrrhiza Glabra Sunflower Oil Isododecane Lycium Barbarum Fruit Magnesium Aluminum Silicate Octyldodecyl Neopentanoate Phenoxyethanol Polysorbate 20 Potassium Cetyl Phosphate Propanediol Pomegranate Hyaluronate Sodium Sodium Metabisulfite Sodium Stearoyl Glutamate .alpha.-tocopherol Acetate Lowbush Blueberry Grape Seed Oil Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-14

Description

Avobenzone 3.00%  Homosalate 7.30% Octocrylene 7.50%  Octisalate 5.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00%  Homosalate 7.30% Octocrylene 7.50%  Octisalate 5.00%

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • 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.
Warnings:

For external use only

Do Not Use
  • on damaged or broken skin.
Drug Facts

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 the risk, regularly use a sunscreen with broad spectrum SPF 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.
Package Labeling:

Active Ingredients

Avobenzone 3.00% 

Homosalate 7.30%

Octocrylene 7.50% 

Octisalate 5.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
  • May stain or damage some fabrics or surfaces.
Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, C9-12 Alkane, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Daucus Carota Sativa (Carrot) Seed Extract, Dihydroxyacetone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Dodecane, Ethyl Vanillin, Ethylhexylglycerin, Glycerin, Glyceryl Stearate Citrate, Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Isododecane, Lactobacillus Ferment, Lycium Barbarum Fruit Extract, Magnesium Aluminum Silicate, Octyldodecyl Neopentanoate, Phenoxyethanol, Polysorbate 20, Potassium Cetyl Phosphate, Propanediol, Punica Granatum Fruit Extract, Sodium Hyaluronate, Sodium Metabisulfite, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vitis Vinifera (Grape) Seed Oil, Water (Aqua), Xanthan Gum

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts.
If Pregnant Or Breast Feeding,

ask a health professional before use.

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.
  • Higher SPF gives more sunburn protection.
  • 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

Warnings:

For external use only

Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 the risk, regularly use a sunscreen with broad spectrum SPF 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.
Package Labeling:

Active Ingredients

Avobenzone 3.00% 

Homosalate 7.30%

Octocrylene 7.50% 

Octisalate 5.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
  • May stain or damage some fabrics or surfaces.
Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, C9-12 Alkane, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Daucus Carota Sativa (Carrot) Seed Extract, Dihydroxyacetone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Dodecane, Ethyl Vanillin, Ethylhexylglycerin, Glycerin, Glyceryl Stearate Citrate, Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Isododecane, Lactobacillus Ferment, Lycium Barbarum Fruit Extract, Magnesium Aluminum Silicate, Octyldodecyl Neopentanoate, Phenoxyethanol, Polysorbate 20, Potassium Cetyl Phosphate, Propanediol, Punica Granatum Fruit Extract, Sodium Hyaluronate, Sodium Metabisulfite, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vitis Vinifera (Grape) Seed Oil, Water (Aqua), Xanthan Gum

When Using This Product (When using this product)
  • keep out of eyes. 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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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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