Bare Republic Mineral Matte Untinted Face Lotion SPF 30

Bare Republic Mineral Matte Untinted Face SPF 30 by

Drug Labeling and Warnings

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

Drug Details [pdf]

BARE REPUBLIC MINERAL MATTE UNTINTED FACE SPF 30- titanium dioxide, zinc oxide lotion 
COOLA, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Bare Republic Mineral Matte Untinted Face Lotion SPF 30

Titanium Dioxide - 5.2%

Zinc Oxide - 2.5%

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun

• 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 a doctor if rash occurs.

Keep out of reach of children. If product is 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 afrer 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

Cyclopentasiloxane, Isopropyl Myristate, Polyamide-5, Stearalkonium Hectorite, Dimethicone Crosspolymer, Polysilicone-11, Silica Silylate, Aluminum Hydroxide, Hydrogen Dimethicone, Vitis Vinifera (Grape) Seed Oil, Butyrospermum Parkii (Shea) Butter, Daucus Carota Sativa (Carrot) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil

Protect this product from excessive heat and direct sun

Call 760-940-2125

BARE REPUBLIC MINERAL MATTE UNTINTED FACE SPF 30 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SHEA BUTTER (UNII: K49155WL9Y)
CARROT SEED OIL (UNII: 595AO13F11)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYAMIDE-5 (UNII: UEM62QMW5F)
RASPBERRY SEED OIL (UNII: 9S8867952A)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-064-01	1 in 1 CARTON	01/01/2019
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/01/2019

Labeler - COOLA, LLC (956990290)

Revised: 11/2022

Document Id: ecabcc99-97d9-1920-e053-2995a90a3dd7

34390-5

Set id: ecabcc89-fb09-41a9-e053-2995a90a8b31

Version: 1

Effective Time: 20221109

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