Eight Saints Chase The Sun Spf-30

Eight Saints Chase The Sun Spf-30
SPL v2
SPL
SPL Set ID 9b19b2b4-d8b9-415d-a217-4a5ef3d75a8c
Route
TOPICAL
Published
Effective Date 2022-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (50 mg) Octisalate (40 mg) Zinc Cation
Inactive Ingredients
Aloe Vera Leaf Water Green Tea Leaf Medium-chain Triglycerides Citric Acid Monohydrate Cyclomethicone 5 Cyclomethicone 4 Carrot Watermelon Decyl Glucoside Dimethicone Ethylhexylglycerin Glycerin Helianthus Annuus Flowering Top Hyaluronic Acid C13-14 Isoparaffin Laureth-7 Lavender Oil Phenoxyethanol Punica Granatum Root Bark Squalane .alpha.-tocopherol Acetate Tridecyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-14

Description

Octocrylene 5.00% Octisalate 5.00% Zinc Oxide 4.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octocrylene 5.00% Octisalate 5.00% Zinc Oxide 4.00%

Uses:

• Helps prevent sunburn • Higher SPF gives more sunburn protection • 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:

• External use only.

Do Not Use

• on damaged or broken skin.

Directions:

• Apply well 15-minuets before sun exposure • Reapply atleast every two hours. Immediately after drying swimming, or sweating. Spending time in the sun increases your risk of 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 sun between 10am–2pm. - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, consult a physician. SUN PROTECTION MEASURES:

Package Labeling:

Active Ingredients

Octocrylene 5.00%

Octisalate 5.00%

Zinc Oxide 4.00%

Other Information:

• Protect the product in this container from excessive heat and direct sun.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/- Capric Triglyceride, Citric Acid, Cyclopentasiloxane, Cyclotetrasiloxane, Dacus Carota Sativa (Carrot) Extract, Citrullus Lanatus (Watermelon) Extract, Decyl Glucoside, Dimethicone, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, C13-14 Isoparaffin, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyacrylamide, Punica Granatum (Pomegranate) Extract, Sclerocarya Birrea (Marula) Oil, Squalane, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.

When Using This Product

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A doctor

• if irritation or rash develops.

If Pregnant Or Breast Feeding,

• ask a health professional before use.

Keep Out of Reach of Children.

• If product is swallowed, get medical attention or contact poison control center immediately.


Structured Label Content

Uses:

• Helps prevent sunburn • Higher SPF gives more sunburn protection • 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:

• External use only.

Do Not Use (Do not use)

• on damaged or broken skin.

Directions:

• Apply well 15-minuets before sun exposure • Reapply atleast every two hours. Immediately after drying swimming, or sweating. Spending time in the sun increases your risk of 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 sun between 10am–2pm. - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, consult a physician. SUN PROTECTION MEASURES:

Package Labeling:

Active Ingredients

Octocrylene 5.00%

Octisalate 5.00%

Zinc Oxide 4.00%

Other Information:

• Protect the product in this container from excessive heat and direct sun.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/- Capric Triglyceride, Citric Acid, Cyclopentasiloxane, Cyclotetrasiloxane, Dacus Carota Sativa (Carrot) Extract, Citrullus Lanatus (Watermelon) Extract, Decyl Glucoside, Dimethicone, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, C13-14 Isoparaffin, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyacrylamide, Punica Granatum (Pomegranate) Extract, Sclerocarya Birrea (Marula) Oil, Squalane, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.

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 irritation or rash develops.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

• ask a health professional before use.

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.


Advanced Ingredient Data


Raw Label Data

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