SEA STAR SPARKLE SPF-50 PARTY CAKE- octinoxate, octisalate, octocrylene, zinc oxide cream

Sea Star Sparkle SPF-50 PARTY CAKE by

Drug Labeling and Warnings

Sea Star Sparkle SPF-50 PARTY CAKE 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%

Octisalate 5.00%

Octocrylene 5.00% 

Zinc Oxide 5.00%

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:
• 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 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 to 2pm.
• Wear long sleeve shirts, pants, hats and sunglasses.
• For children under 6 months, consult a physician.

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, Glitter: 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.

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 Right Reserved.

Package Labeling

INGREDIENTS AND APPEARANCE

SEA STAR SPARKLE SPF-50 PARTY CAKE 
octinoxate, octisalate, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72085-148
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STYRENE (UNII: 44LJ2U959V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72085-148-04	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)