BARE REPUBLIC MINERAL SHIMMER SPF 30 DIAMOND DUST- titanium dioxide, zinc oxide lotion

Bare Republic Mineral Shimmer SPF 30 Diamond Dust by

Drug Labeling and Warnings

Bare Republic Mineral Shimmer SPF 30 Diamond Dust by is a Otc medication manufactured, distributed, or labeled by COOLA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide - 6.4%

Zinc Oxide - 4.2%

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 ask doctor if skin rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Shake well. Apply liberally 15 minutes before sun exposure
• Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from: 10 a.m. – 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

OTHER SAFETY INFORMATION

• Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Water, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetyl Alcohol, Synthetic Fluorphlogopite, Sodium Stearoyl Glutamate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Polyhydroxystearic Acid, Tocopherol, Glycerin, Tocopherol, Moringa Oleifera Seed Oil, Aloe Barbadensis Leaf Juice, Citric Acid, Coco-Glucoside, Glyceryl Stearate, Xanthan Gum, Aluminum Hydroxide, Caprylyl Glycol, Stearic Acid, Silica, Calcium Sodium Borosilicate, Sodium Gluconate, Caprylhydroxamic Acid, Iron Oxides, Mica, Amethyst Powder

QUESTIONS

Call 760-940-2125

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BARE REPUBLIC MINERAL SHIMMER SPF 30 DIAMOND DUST 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.4 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM GLUCONATE (UNII: R6Q3791S76)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
COCO GLUCOSIDE (UNII: ICS790225B)
SUNFLOWER OIL (UNII: 3W1JG795YI)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-063-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2018

Labeler - COOLA, LLC (956990290)