MIAMI BEACH BODY WHITE GOLD SPF 50- titanium dioxide, zinc oxide cream

Miami Beach Body White Gold SPF 50 by

Drug Labeling and Warnings

Miami Beach Body White Gold SPF 50 by is a Otc medication manufactured, distributed, or labeled by Miami Beach Brands, Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 6.00%

Zinc Oxide 12.50%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn.
• If used as directed with other sun protection measure (see directions), decrease 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.

Keep out of reach of children.

If 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 and 2pm.

- Wear long sleeve shirts, pants, hats and sunglasses.

- For children under 6-months, consult a physician.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylgycerin, Ethylhexyl Palmitate, Glycerin, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polysorbate-20, Tetrasodium EDTA, Styrene/Acrylates Copolymer, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum, Zemea (Corn) Propanediol.

Addition Information:

Protect this product from excessive heat and direct sunlight.

Package Labeling:

INGREDIENTS AND APPEARANCE

MIAMI BEACH BODY WHITE GOLD SPF 50 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71130-236
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	125 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATERMELON (UNII: 231473QB6R)
CARROT SEED OIL (UNII: 595AO13F11)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE SODIUM (UNII: MP1J8420LU)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71130-236-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

Labeler - Miami Beach Brands, Corp. (080429811)