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

Purpose

Sunscreen

Description

Titanium Dioxide 10% Zinc Oxide 10%


Medication Information

Warnings

For external use only.

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

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

Description

Titanium Dioxide 10% Zinc Oxide 10%

Do Not Use
  • on damaged or broken skin.
Package Labeling:

Active Ingredients

Titanium Dioxide 10% Zinc Oxide 10%

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

Warnings

For external use only.

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

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

Do Not Use (Do not use)
  • on damaged or broken skin.
Package Labeling:

Active Ingredients (Active ingredients)

Titanium Dioxide 10% Zinc Oxide 10%

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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