Sea Star Sparkle Spf-50 Very Berry

Sea Star Sparkle Spf-50 Very Berry
SPL v3
SPL
SPL Set ID 88c403ea-7c78-423e-b05e-1e17c21c5a53
Route
TOPICAL
Published
Effective Date 2018-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Octisalate (50 mg) Octocrylene Zinc Cation
Inactive Ingredients
Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Aloe Vera Leaf Water Green Tea Leaf Medium-chain Triglycerides Cetearyl Olivate Cetyl Alcohol Citric Acid Monohydrate Ethylhexylglycerin Poly(methyl Methacrylate; 450000 Mw) Fd&c Yellow No. 5 D&c Red No. 7 Glycerin Glyceryl Monostearate Phenoxyethanol Polysorbate 20 Sorbitan Olivate Styrene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-01

Description

Octinoxate 7.50% Octisalate 5.00% Octocrylene 5.00%  Zinc Oxide 5.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.50% Octisalate 5.00% Octocrylene 5.00%  Zinc Oxide 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 two-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 to 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.

Drug Facts

Package Labeling

Other Ingredients

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Ethylhexylglycerin, : Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethane-33, FD&C Yellow #5, D&C Red #7, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Tocopherol Acetate (Vitamin E), Zemea (Corn) Propanediol. Glitter

Other Information

Protect this product from excessive heat and direct sunlight.

Active Ingredients

Octinoxate 7.50%

Octisalate 5.00%

Octocrylene 5.00% 

Zinc Oxide 5.00%

Questions Or Comments?

Contact us directly at 1-888-601-0441

Distr. by/par: Sunshine & Glitter

MJ Products Association LLC

9750 NW 17th Street, Miami, FL 33172

www.sunshineglitter.com

All Right Reserved.

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 two-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 to 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.

Drug Facts

Package Labeling

Other Ingredients

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Ethylhexylglycerin, : Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethane-33, FD&C Yellow #5, D&C Red #7, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Tocopherol Acetate (Vitamin E), Zemea (Corn) Propanediol. Glitter

Other Information (Other information)

Protect this product from excessive heat and direct sunlight.

Active Ingredients

Octinoxate 7.50%

Octisalate 5.00%

Octocrylene 5.00% 

Zinc Oxide 5.00%

Questions Or Comments? (Questions or comments?)

Contact us directly at 1-888-601-0441

Distr. by/par: Sunshine & Glitter

MJ Products Association LLC

9750 NW 17th Street, Miami, FL 33172

www.sunshineglitter.com

All Right Reserved.

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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