Jacket Spf-50 Broad Spectrum Sunscreen

Jacket Spf-50 Broad Spectrum Sunscreen
SPL v3
SPL
SPL Set ID fcc45edd-098c-4f27-9712-0db36cfa0fdc
Route
TOPICAL
Published
Effective Date 2024-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (60 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Allantoin Aloe Vera Leaf Water Ascorbic Acid Green Tea Leaf Medium-chain Triglycerides Polyoxyl 20 Cetostearyl Ether Cetearyl Olivate Cetyl Alcohol Cucumber Cyclomethicone 5 Cyclomethicone 4 Cymbopogon Citratus Leaf Dimethicone Ethylhexylglycerin Ethylhexyl Palmitate Glycerin Glyceryl Monostearate Licorice Helianthus Annuus Flowering Top Magnesium Aluminum Silicate Phenoxyethanol Polysorbate 20 Pomegranate Sorbitan Olivate Stearyl Alcohol .alpha.-tocopherol Acetate Tridecyl Salicylate Corn Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-15
Description

Zinc Oxide 6.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 5.00%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 6.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 5.00%

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.
Warnings
  • For external use only.
Directions

• Apply liberally 15 minutes before sun exposure • Reapply: *At least every 2 hours *Immediately after swimming, sweating or towel drying 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 -2pm *Wear long sleeve shirts, pants, hats and sunglasses *For children under 6 months, consult a physician.



Sun Protection Measures:

Drug Facts

Do Not Use 

on damaged or broken skin.

Other Information

Protect this product from excessive heat and direct sunlight.

Other Ingredients

Acrylates Copolymer, Allantoin, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Arbutin, Ascorbic Acid (Vitamin C), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceteareth 20, Cetearyl Olivate, Cetyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Cymbopogon Schoenanthus (Lemongrass) Oil, Dimethicone, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Magnesium Aluminum Silicate, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Zema (Corn) Propanediol

Package Labeling:

Active Ingredients

Zinc Oxide 6.00%

Homosalate 10.00%

Octisalate 5.00%

Octocrylene 5.00%

When Using This Product 

keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children.

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

Stop Use and Consult Physician

if irritation or rash develops

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.
Purpose

Sunscreen

Warnings
  • For external use only.
Directions

• Apply liberally 15 minutes before sun exposure • Reapply: *At least every 2 hours *Immediately after swimming, sweating or towel drying 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 -2pm *Wear long sleeve shirts, pants, hats and sunglasses *For children under 6 months, consult a physician.



Sun Protection Measures:

Drug Facts

Do Not Use  (Do not use )

on damaged or broken skin.

Other Information

Protect this product from excessive heat and direct sunlight.

Other Ingredients

Acrylates Copolymer, Allantoin, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Arbutin, Ascorbic Acid (Vitamin C), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceteareth 20, Cetearyl Olivate, Cetyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Cymbopogon Schoenanthus (Lemongrass) Oil, Dimethicone, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Magnesium Aluminum Silicate, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Zema (Corn) Propanediol

Package Labeling:

Active Ingredients

Zinc Oxide 6.00%

Homosalate 10.00%

Octisalate 5.00%

Octocrylene 5.00%

When Using This Product  (When using this product )

keep out of eyes. Rinse with water to remove.

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.

Stop Use and Consult Physician (Stop use and consult physician)

if irritation or rash develops

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:30.382065 · Updated: 2026-03-14T23:03:35.185430