Beach Gypsy Spf-30

Beach Gypsy Spf-30
SPL v5
SPL
SPL Set ID a518e048-5614-4b67-b6fa-e1f2e380f352
Route
TOPICAL
Published
Effective Date 2023-11-16
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

Identifiers & Packaging

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

Description

Octinoxate 7.50% Octocrylene 7.00% Octisalate 4.00% Avobenzone 3.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.50% Octocrylene 7.00% Octisalate 4.00% Avobenzone 3.00%

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:
  • Al 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 decreases 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 and 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 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, FD&C Yellow #5, Aluminum; Glyceryl Stearate, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanedio.

Active Ingredients

Octinoxate 7.50%

Octocrylene 7.00%

Octisalate 4.00%

Avobenzone 3.00%

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 Rights 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 (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 (DIRECTIONS)
  • Apply liberally 15 minutes before sun exposure. REAPPLY:
  • Al 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 decreases 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 and 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 Information (OTHER INFORMATION)

Protect this product from excessive heat and direct sunlight.

Other Ingredients (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, FD&C Yellow #5, Aluminum; Glyceryl Stearate, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanedio.

Active Ingredients (ACTIVE INGREDIENTS)

Octinoxate 7.50%

Octocrylene 7.00%

Octisalate 4.00%

Avobenzone 3.00%

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 Rights 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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