Aruba Aloe Sport Line Broad Spectrum Spf 50 Anti-chafing Cream

Aruba Aloe Sport Line Broad Spectrum Spf 50 Anti-chafing Cream
SPL v2
SPL
SPL Set ID cb3918b2-14b6-424c-9251-d71dc92353c4
Route
TOPICAL
Published
Effective Date 2020-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (100 mg) Zinc Cation
Inactive Ingredients
Water Decyl Oleate Petrolatum Aloe Vera Leaf Medium-chain Triglycerides White Wax Dicocoyl Pentaerythrityl Distearyl Citrate Sorbitan Sesquioleate Dimethicone Butyloctyl Salicylate Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Cetostearyl Alcohol Microcrystalline Wax Aluminum Stearates Glycerin .alpha.-tocopherol Acetate Phenoxyethanol Ascorbic Acid Jojoba Oil Stearic Acid Chlorphenesin Caprylyl Glycol Citric Acid Monohydrate Aluminum Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-15

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.
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), Decyl Oleate, Petrolatum, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Caprylic/Capric Triglyceride, Cera Alba (Beeswax), Dicocoyl Pentaerythrityl Distearyl Citrate, Sorbitane Sesquioleate, Dimethicone, Butyloctyl Salicylate, Dimethicone Crosspolymer,  Cetearyl Alcohol, Cera Microcristallina (Microcristalline Wax), Aluminum Stearates, Glycerin, Tocopheryl Acetate (Vitamin E Acetate), Sodium Polyacrylate, Phenoxyethanol, Fragrance (Parfum), Ascorbic Acid (Vitamin C), Simmondsia Chinensis Seed (Jojoba) Oil, Stearic Acid,  Chlorphenesin, Caprylyl Glycol, Citric Acid, 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.

f 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.
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), Decyl Oleate, Petrolatum, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Caprylic/Capric Triglyceride, Cera Alba (Beeswax), Dicocoyl Pentaerythrityl Distearyl Citrate, Sorbitane Sesquioleate, Dimethicone, Butyloctyl Salicylate, Dimethicone Crosspolymer,  Cetearyl Alcohol, Cera Microcristallina (Microcristalline Wax), Aluminum Stearates, Glycerin, Tocopheryl Acetate (Vitamin E Acetate), Sodium Polyacrylate, Phenoxyethanol, Fragrance (Parfum), Ascorbic Acid (Vitamin C), Simmondsia Chinensis Seed (Jojoba) Oil, Stearic Acid,  Chlorphenesin, Caprylyl Glycol, Citric Acid, 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.)

f swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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