Aruba Aloe Spf 50+ Mineral Sunscreen

Aruba Aloe Spf 50+ Mineral Sunscreen
SPL v2
SPL
SPL Set ID d828500b-4f3d-2922-e053-2a95a90aa44c
Route
TOPICAL
Published
Effective Date 2022-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (100 mg) Zinc Cation
Inactive Ingredients
Water Butyloctyl Salicylate Medium-chain Triglycerides Aloe Vera Leaf Glyceryl Monostearate Cetearyl Isononanoate Polysorbate 60 Cetostearyl Alcohol Dimethicone Polyoxyl 20 Cetostearyl Ether Propylene Glycol Coconut Oil Phenoxyethanol .alpha.-tocopherol Acetate Cetyl Palmitate Ceteareth-12 Caprylyl Glycol Chlorphenesin Jojoba Oil Ascorbic Acid Citric Acid Monohydrate Edetate Disodium Anhydrous Triethoxycaprylylsilane Aluminum Oxide Polyhydroxystearic Acid (2300 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-20

Description

Titanium Dioxide 10% Zinc Oxide 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 10% Zinc Oxide 10%

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.
  • 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: Sun Protection Measures.
  • 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

Titanium Dioxide 10% Zinc Oxide 10%

Inactive Ingredients

Water (Aqua/Eau), Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Glyceryl Stearate, Cetearyl Isononanoate, Polysorbate 60, VP/Eicosene Copolymer, Cetearyl Alcohol, Dimethicone Crosspolymer, Dimethicone, Ceteareth-20, Propylene Glycol, Fragrance (Parfum), Cocos Nucifera (Coconut) Oil, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), Cetyl Palmitate, Ceteareth-12, Caprylyl Glycol, Chlorphenesin, Simmondsia Chinensis (Jojoba) Seed Oil, Ascorbic Acid (Vitamin C), Citric Acid, Disodium EDTA Powder, Triethoxycaprylylsilane, Alumina, Polyhydroxystearic Acid.

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.
  • 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: Sun Protection Measures.
  • 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)

Titanium Dioxide 10% Zinc Oxide 10%

Inactive Ingredients (Inactive ingredients)

Water (Aqua/Eau), Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Glyceryl Stearate, Cetearyl Isononanoate, Polysorbate 60, VP/Eicosene Copolymer, Cetearyl Alcohol, Dimethicone Crosspolymer, Dimethicone, Ceteareth-20, Propylene Glycol, Fragrance (Parfum), Cocos Nucifera (Coconut) Oil, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), Cetyl Palmitate, Ceteareth-12, Caprylyl Glycol, Chlorphenesin, Simmondsia Chinensis (Jojoba) Seed Oil, Ascorbic Acid (Vitamin C), Citric Acid, Disodium EDTA Powder, Triethoxycaprylylsilane, Alumina, Polyhydroxystearic Acid.

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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