Jacket Spf 50+ Cream

Jacket Spf 50+ Cream
SPL v3
SPL
SPL Set ID b82b8a46-8009-416e-8718-296a23106914
Route
TOPICAL
Published
Effective Date 2016-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (75 mg) Octinoxate (50 mg) Octisalate Oxybenzone
Inactive Ingredients
Aloe Vera Leaf Water Arbutin Ascorbic Acid Green Tea Leaf Medium-chain Triglycerides Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Cetearyl Olivate Cucumber Cymbopogon Schoenanthus Oil Dimethicone Ethylhexylglycerin Ethylhexyl Palmitate Glycerin Glyceryl Monostearate Glycyrrhiza Glabra Helianthus Annuus Flowering Top Phenoxyethanol Polysorbate 20 Pomegranate Sorbitan Olivate Stearyl Alcohol .alpha.-tocopherol Corn Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-11-18
Description

Zinc Oxide 7.50% Octinoxate 7.50% Octisalate 5.00% Oxybenzone 5.00%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 7.50% Octinoxate 7.50% Octisalate 5.00% Oxybenzone 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:  Sun Protection Measures:
  • 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. 
Do Not Use 

on damaged or broken skin

Package Labeling:

Active Ingredients

Zinc Oxide 7.50%

Octinoxate 7.50%

Octisalate 5.00%

Oxybenzone 5.00%

Other Ingredients 

Acrylates Copolymer, 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 Alcohol, Cetearyl Olivate, Cetyl Alcohol Cucumis Sativus (Cucumber) Fruit Extract, Cymbopogon Schoenanthus (Lemongrass) Oil, Dimethicone, Ethylhexylgycerin, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Stearyl Alcohol, Tocopheyl Acetate (Vitamin E), Zema (Corn), Propanediol

When Using This Product 

keep out of eyes. Rinse with water to remove

Keep Out If 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:  Sun Protection Measures:
  • 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. 
Do Not Use  (Do not use )

on damaged or broken skin

Package Labeling:

Active Ingredients

Zinc Oxide 7.50%

Octinoxate 7.50%

Octisalate 5.00%

Oxybenzone 5.00%

Other Ingredients 

Acrylates Copolymer, 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 Alcohol, Cetearyl Olivate, Cetyl Alcohol Cucumis Sativus (Cucumber) Fruit Extract, Cymbopogon Schoenanthus (Lemongrass) Oil, Dimethicone, Ethylhexylgycerin, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Stearyl Alcohol, Tocopheyl Acetate (Vitamin E), Zema (Corn), Propanediol

When Using This Product  (When using this product )

keep out of eyes. Rinse with water to remove

Keep Out If Reach of Children. (Keep out if reach of children.)

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

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

irritation or rash develops

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:14.296939 · Updated: 2026-03-14T23:01:41.296752