BEACH GYPSY SPF-30- octinoxate, octocrylene, octisalate, avobenzone cream

Beach Gypsy SPF-30 by

Drug Labeling and Warnings

Beach Gypsy SPF-30 by is a Otc medication manufactured, distributed, or labeled by MJ Products Association, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENTS

Octinoxate 7.50%

Octocrylene 7.00%

Octisalate 4.00%

Avobenzone 3.00%

PURPOSE

Sunscreen

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.

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and consult physician

if irritation or rash develops.

Keep out of reach of children.

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

DIRECTIONS

• Apply liberally 15 minutes before sun exposure. REAPPLY:
• Al 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 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:
• 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.

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.

OTHER INFORMATION

Protect this product from excessive heat and direct sunlight.

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.

Package Labeling

INGREDIENTS AND APPEARANCE

BEACH GYPSY SPF-30 
octinoxate, octocrylene, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72085-146
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARGAN OIL (UNII: 4V59G5UW9X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
CARROT SEED OIL (UNII: 595AO13F11)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
REGENERATED CELLULOSE (UNII: BX81F82EWG)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM (UNII: CPD4NFA903)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN OLIVATE (UNII: MDL271E3GR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72085-146-04	113 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2018

Labeler - MJ Products Association, LLC (081022202)