Aruba Sun Spf Mineral Lotion

Aruba Sun Spf Mineral Lotion
SPL v3
SPL
SPL Set ID 0aafab44-0481-2a22-e063-6294a90abef2
Route
TOPICAL
Published
Effective Date 2023-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.5 g) Zinc Oxide (4 g)
Inactive Ingredients
Ethylhexyl Palmitate Edetate Disodium Alkyl (c12-15) Benzoate Aluminum Starch Octenylsuccinate Styrene/acrylamide Copolymer (mw 500000) Glycerin Ethylhexylglycerin Phenoxyethanol Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Sorbitan Olivate Dimethicone 200 Hydrated Silica Water Hydrogen Dimethicone (20 Cst) Sodium Chloride Rosemary Vitis Vinifera Seed Green Tea Leaf Aluminum Oxide Aloe Vera Leaf Mentha Piperita Leaf Cucumber Pomegranate Juice Rice Bran, Defatted Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-23

Description

Titanium Dioxide 4.4%, Zinc Oxide 4%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 4.4%, Zinc Oxide 4%

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.

Label

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

Stop use and ask a doctor if rash occurs.

Directions

Apply liberally 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 n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

  • limit time in the sun, especially from 10 am to 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

Active Ingredients

Titanium Dioxide 4.4%, Zinc Oxide 4%

Inactive Ingredients

Water, ethylhexyl palmitate, C12-15 alkyl benzoate, styrene/acrylates copolymer, glycerin, sorbitan olivate, cetyl PEG/PPG-10/1 dimethicone, dimethicone, aluminum starch octenylsuccinate, sodium chloride, silica, aloe barbadensis leaf extract, cucumis sativus (cucumber) fruit extract, mentha piperita (peppermint) leaf extract, punica granatum fruit juice, oryza sativa (rice) bran water, rosmarinus officinalis (rosemary) leaf extract, vitis vinifera (grade) seed extract, camellia sinensis leaf extract, ethylhexylglycerin, propanediol, disodium EDTA, phenoxyethanol, alumina, hydrogen dimethicone

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.

Label

Purpose

Sunscreen

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

Stop use and ask a doctor if rash occurs.

Directions

Apply liberally 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 n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

  • limit time in the sun, especially from 10 am to 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

Active Ingredients

Titanium Dioxide 4.4%, Zinc Oxide 4%

Inactive Ingredients

Water, ethylhexyl palmitate, C12-15 alkyl benzoate, styrene/acrylates copolymer, glycerin, sorbitan olivate, cetyl PEG/PPG-10/1 dimethicone, dimethicone, aluminum starch octenylsuccinate, sodium chloride, silica, aloe barbadensis leaf extract, cucumis sativus (cucumber) fruit extract, mentha piperita (peppermint) leaf extract, punica granatum fruit juice, oryza sativa (rice) bran water, rosmarinus officinalis (rosemary) leaf extract, vitis vinifera (grade) seed extract, camellia sinensis leaf extract, ethylhexylglycerin, propanediol, disodium EDTA, phenoxyethanol, alumina, hydrogen dimethicone

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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