Seaweed Bath Co. Spf-50 Sport Lotion

Seaweed Bath Co. Spf-50 Sport Lotion
SPL v2
SPL
SPL Set ID f01516bf-8aed-4402-a3f9-ef11c54d46b3
Route
TOPICAL
Published
Effective Date 2020-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Zinc Cation (85 mg) Octisalate (50 mg)
Inactive Ingredients
Aloe Vera Leaf Benzyl Alcohol Shea Butter Calendula Officinalis Flower Green Tea Leaf Medium-chain Triglycerides Cetostearyl Alcohol Citric Acid Monohydrate Watermelon Coconut Oil Decyl Glucoside Dehydroacetic Acid Fucus Vesiculosus Glycerin Glyceryl Monostearate Helianthus Annuus Flowering Top Hydroxyethyl Cellulose, Unspecified Avocado Oil Jojoba Oil Cocoa .alpha.-tocopherol Acetate Tridecyl Salicylate Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-23

Description

Octocrylene 10.0% Zinc Oxide 8.5% Octisalate 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octocrylene 10.0% Zinc Oxide 8.5% Octisalate 5.0%

Uses:

• Helps prevent sunburn. • Higher SPF gives more sunburn protection. • Retains SPF after 80 minutes of swimming or sweating.

Warnings:

For external use only.

Do Not Use

on damaged or broken skin.

Questions?

Call toll free 1-877-317-3106

Directions:

• Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months: ask a doctor. • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • A t least every two 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 of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. – 2 p.m. • Wear long-sleeve shirts, pants, hats and sunglasses. Sun Protection Measures:

Active Ingredient

Octocrylene 10.0%

Zinc Oxide 8.5%

Octisalate 5.0%

Package Labeling:

Other Information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients:

Algae Extract, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter), Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dehydroacetic Acid, Fucus Vesiculosus (Bladderwrack Seaweed) Extract, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Natural Fragrance, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Simmondsia Chinensis (Jojoba) Oil, Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Water, Xanthan Gum.

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. • Higher SPF gives more sunburn protection. • Retains SPF after 80 minutes of swimming or sweating.

Purpose

Sunscreen

Warnings:

For external use only.

Do Not Use (Do not use)

on damaged or broken skin.

Questions?

Call toll free 1-877-317-3106

Directions:

• Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months: ask a doctor. • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • A t least every two 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 of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. – 2 p.m. • Wear long-sleeve shirts, pants, hats and sunglasses. Sun Protection Measures:

Active Ingredient

Octocrylene 10.0%

Zinc Oxide 8.5%

Octisalate 5.0%

Package Labeling:

Other Information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients:

Algae Extract, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter), Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dehydroacetic Acid, Fucus Vesiculosus (Bladderwrack Seaweed) Extract, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Natural Fragrance, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Simmondsia Chinensis (Jojoba) Oil, Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Water, Xanthan Gum.

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 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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