Hydrating Aloe Rich Suncare Spf 15 Broad Spectrum Very Water Resistant (80 Minutes) Uva/uvb Protection

Hydrating Aloe Rich Suncare Spf 15 Broad Spectrum Very Water Resistant (80 Minutes) Uva/uvb Protection
SPL v1
SPL
SPL Set ID 0de03832-48e8-481a-b3a2-c4dc2be3df25
Route
TOPICAL
Published
Effective Date 2024-08-30
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
Aloe Vera Leaf Water 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 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.

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

Avobenzone 3%

Homosalate 7.34%

Octocrylene 5%

Octyl Salicylate 5%

Package Labelling:

Inactive Ingredients

Water (Aqua/Eau), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), 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.

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.

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

Avobenzone 3%

Homosalate 7.34%

Octocrylene 5%

Octyl Salicylate 5%

Package Labelling:

Inactive Ingredients (Inactive ingredients)

Water (Aqua/Eau), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), 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.

When Using This Product (When using this product)

keep out of eyes.Rinse with water to remove

Stop Use and Ask A Doctor (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

All Sections (JSON)