Beach Gypsy Glitter Sunscreen Spf-30

Beach Gypsy Glitter Sunscreen Spf-30
SPL v3
SPL
SPL Set ID 1d224ecf-d356-424e-b181-ad8692f82b03
Route
TOPICAL
Published
Effective Date 2020-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Octocrylene (70 mg) Octisalate (40 mg) Avobenzone (30 mg)
Inactive Ingredients
Aloe Vera Leaf Water Argan Oil Green Tea Leaf Cetearyl Olivate Cetyl Alcohol Citric Acid Monohydrate Coconut Oil Carrot Seed Oil Ethylhexylglycerin Regenerated Cellulose Fd&c Yellow No. 5 Aluminum Glyceryl Monostearate Phenoxyethanol Polysorbate 20 Sorbitan Olivate .alpha.-tocopherol Acetate Corn Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-10

Description

Homosalate 10.00% Octocrylene 5.00% Octisalate 5.00% Zinc Oxide 4.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10.00% Octocrylene 5.00% Octisalate 5.00% Zinc Oxide 4.00%

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.
  • At least every two-hours.
  • Immediately after swimming, sweating or towel drying. SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use suncreen with broad spectrum protection and on SPF rating of 15 or higher, along with other sun protection measures including: Limit time in the sun, especially between 10am and 2pm. 
  • Wear long sleeve shirts, pants, hats, and sunglasses.
  • For children under 6 months, consult a physician.

REAPPLY:

Do Not Use 
  • on damaged or broken skin.
Other Information

Protect this product from excessive heat and direct sunlight.

Other Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel), Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Camellia Sinensis (Green Tea) Extract, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylglycerin, Glitter: Regenerated Cellulose/Rayon, FD&C Yellow #5, Aluminum; Glyceryl Stearate, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Tocopherol Acetate (Vitamin E), Zemea (Corn) Propanediol.

Package Labeling:

Active Ingredients

Homosalate 10.00%

Octocrylene 5.00%

Octisalate 5.00%

Zinc Oxide 4.00%

Questions Or Comments?

Contact us directly at 1-888-601-0441

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 (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 (PURPOSE)

Sunscreen

Warnings (WARNINGS)

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • At least every two-hours.
  • Immediately after swimming, sweating or towel drying. SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use suncreen with broad spectrum protection and on SPF rating of 15 or higher, along with other sun protection measures including: Limit time in the sun, especially between 10am and 2pm. 
  • Wear long sleeve shirts, pants, hats, and sunglasses.
  • For children under 6 months, consult a physician.

REAPPLY:

Do Not Use  (Do not use )
  • on damaged or broken skin.
Other Information

Protect this product from excessive heat and direct sunlight.

Other Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel), Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Camellia Sinensis (Green Tea) Extract, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylglycerin, Glitter: Regenerated Cellulose/Rayon, FD&C Yellow #5, Aluminum; Glyceryl Stearate, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Tocopherol Acetate (Vitamin E), Zemea (Corn) Propanediol.

Package Labeling:

Active Ingredients (ACTIVE INGREDIENTS)

Homosalate 10.00%

Octocrylene 5.00%

Octisalate 5.00%

Zinc Oxide 4.00%

Questions Or Comments? (Questions or comments?)

Contact us directly at 1-888-601-0441

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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