Seven Minerals Skin Friendly Spf-30

Seven Minerals Skin Friendly Spf-30
SPL v2
SPL
SPL Set ID bd60cf89-e0e9-48ad-b174-1ecf72557d9c
Route
TOPICAL
Published
Effective Date 2020-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Aloe Vera Leaf Water Green Tea Leaf Medium-chain Triglycerides Cetostearyl Alcohol Cetearyl Olivate Watermelon Coconut Oil Cyclomethicone 5 Carrot Glycerin Glyceryl Caprylate Glyceryl 1-undecylenate Helianthus Annuus Flowering Top Magnesium Chloride Magnesium Sulfate, Unspecified Form Mango Polysorbate 20 Sodium Hydroxide Sorbitan Olivate Stearic Acid Tocopherol Corn Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-03

Description

Avobenzone 3.00%, Octisalate 5.00%, Octocrylene 5.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00%, Octisalate 5.00%, Octocrylene 5.00%

Uses:

• Helps prevent sunburn. • Higher SPF gives more sunburn protection. • Retains SPF after 80 minutes of swimming or sweating. • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Warnings:

• For external use only

Do Not Use
  • on damaged or broken skin.
Directions:

• Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age: ask a doctor. • 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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: • Limit time in the sun, especially between 10am and 2pm. • Wear long sleeve shirts, pants, hats and sunglasses.

SUN PROTECTION MEASURES:

Package Labeling:

Active Ingredients

Avobenzone 3.00%, Octisalate 5.00%, Octocrylene 5.00%

Other Information:

• Protect this product from excessive heat and direct sunlight.

Inactive Ingredients:

Acrylates Copolymer, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Amodimethicone, Aqua (Deionized Water), Bis Vinyl Dimethicone/ Dimethicone Copolymer, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Butter, Polysorbate-20, Sodium Hydroxide, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Zemea (Corn) Propanediol.

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor
  • if rash or irritation develops and lasts.
Keep Out of Reach of Children.
  • If product is swallowed, get medical attention or contact poison control center immediately.

Structured Label Content

Uses: (USES:)

• Helps prevent sunburn. • Higher SPF gives more sunburn protection. • Retains SPF after 80 minutes of swimming or sweating. • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Purpose

Sunscreen

Warnings: (WARNINGS:)

• For external use only

Do Not Use (Do not use)
  • on damaged or broken skin.
Directions: (DIRECTIONS:)

• Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age: ask a doctor. • 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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: • Limit time in the sun, especially between 10am and 2pm. • Wear long sleeve shirts, pants, hats and sunglasses.

SUN PROTECTION MEASURES:

Package Labeling:

Active Ingredients

Avobenzone 3.00%, Octisalate 5.00%, Octocrylene 5.00%

Other Information: (OTHER INFORMATION:)

• Protect this product from excessive heat and direct sunlight.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Acrylates Copolymer, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Amodimethicone, Aqua (Deionized Water), Bis Vinyl Dimethicone/ Dimethicone Copolymer, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Butter, Polysorbate-20, Sodium Hydroxide, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Zemea (Corn) Propanediol.

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 or irritation develops and lasts.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • If product is swallowed, get medical attention or contact poison control center immediately.

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Raw Label Data

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