Aruba Aloe Broad Spectrum Spf 15 Lip Sunscreen & Moisturizer

Aruba Aloe Broad Spectrum Spf 15 Lip Sunscreen & Moisturizer
SPL v1
SPL
SPL Set ID 9e3ed6dc-14ba-4bb2-a633-1a1fe92099ce
Route
TOPICAL
Published
Effective Date 2024-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (73.4 mg) Octocrylene (50 mg) Octisalate
Inactive Ingredients
Petrolatum Cocoa Butter Candelilla Wax Coconut Oil Aloe Vera Leaf .alpha.-tocopherol Acetate Sorbitan Monooleate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-14

Description

Avobenzone (3%), Homosalate (7.34%), Octocrylene (5%), Octyl Salicylate (5%)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone (3%), Homosalate (7.34%), Octocrylene (5%), 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 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.
Do Not Use

on damaged or broken skin.

Drug Facts

Other Information
  • protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Avobenzone (3%), Homosalate (7.34%), Octocrylene (5%), Octyl Salicylate (5%)

Inactive Ingredients

Petrolatum, Theobroma Cacao (Cocoa) Seed Butter, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Tocopheryl Acetate (Vitamin E Acetate), Sorbitan Oleate.

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 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.
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.
Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone (3%), Homosalate (7.34%), Octocrylene (5%), Octyl Salicylate (5%)

Inactive Ingredients (Inactive ingredients)

Petrolatum, Theobroma Cacao (Cocoa) Seed Butter, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Tocopheryl Acetate (Vitamin E Acetate), Sorbitan Oleate.

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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