Aruba Aloe Hydrating Aloe Rich Sunscreen Spf 50+

Aruba Aloe Hydrating Aloe Rich Sunscreen Spf 50+
SPL v1
SPL
SPL Set ID acda1640-0d35-43dc-8734-d47b00cc85ed
Route
TOPICAL
Published
Effective Date 2024-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (73.4 mg) Octocrylene (100 mg) Ethylhexyl Salicylate (50 mg)
Inactive Ingredients
Water Aloe Vera Leaf Butyloctyl Salicylate Cetostearyl Alcohol Ceteth-20 Phosphate Dimethicone .alpha.-tocopherol Acetate Jojoba Oil Coconut Oil Caprylyl Glycol Myristyl Laurate Glyceryl Laurate Myristyl Myristate Carbomer Homopolymer, Unspecified Type Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-11

Description

Avobenzone 3% Homosalate 7.34% Octocrylene 10% Octyl Salicylate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 7.34% Octocrylene 10% Octyl Salicylate 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.
Warnings

For external use only.

Directions
  • apply generously 15 minutes before sun exposure.
  • 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 ofskin cancer and early skin aging. To decrease this risk, regularly use asunscreen with a broad spectrum SPF value of 15 or higher and other sunprotection 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.
Do Not Use
  • on damaged or broken skin.
Drug Facts

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

Avobenzone 3%

Homosalate 7.34%

Octocrylene 10%

Octyl Salicylate 5%

Inactive Ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Butyloctyl Salicylate, VP/Eicosene Copolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Dimethicone, Tocopheryl Acetate (Vitamin E Acetate), Simmondsia Chinensis (Jojoba) Seed Oil, Cocos Nucifera (Coconut) Oil, Caprylyl Glycol, Myristyl Laurate, Glyceryl Laurate, Myristyl Myristate, Fragrance (Parfum), Glyceryl Undecylenate, Carbomer, Aminomethyl Propanol.

Package Labeling:59ml

Package Labeling:177ml

When Using This Product
  • keep out of eyes. Rinse with water to remove.
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.
Purpose

Sunscreen

Warnings

For external use only.

Directions
  • apply generously 15 minutes before sun exposure.
  • 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 ofskin cancer and early skin aging. To decrease this risk, regularly use asunscreen with a broad spectrum SPF value of 15 or higher and other sunprotection 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.
Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

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

Avobenzone 3%

Homosalate 7.34%

Octocrylene 10%

Octyl Salicylate 5%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Butyloctyl Salicylate, VP/Eicosene Copolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Dimethicone, Tocopheryl Acetate (Vitamin E Acetate), Simmondsia Chinensis (Jojoba) Seed Oil, Cocos Nucifera (Coconut) Oil, Caprylyl Glycol, Myristyl Laurate, Glyceryl Laurate, Myristyl Myristate, Fragrance (Parfum), Glyceryl Undecylenate, Carbomer, Aminomethyl Propanol.

Package Labeling:59ml

Package Labeling:177ml

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 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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