Mineral Wear Loose Powder 10948-10950; 69514-307

Mineral Wear Loose Powder by

Drug Labeling and Warnings

Mineral Wear Loose Powder by is a Otc medication manufactured, distributed, or labeled by Markwins Beauty Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MINERAL WEAR LOOSE POWDER- titanium dioxide, zinc oxide powder 
Markwins Beauty Brands

----------

Mineral Wear Loose Powder 10948-10950; 69514-307

Titanium dioxide 12%

Zinc oxide 4.2%

Sunscreen

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

For external use only

Do not use on damage 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

If swallowed, get medical help or contact a Poison Control Center right away.

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months of age: Ask a doctor
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 value 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-sleeved shirts, pants, hats, and sunglasses

Mica, Lauroyl Lysine, Zinc Stearate, Boron Nitride, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, o-Cymen-5-ol, Iron Oxides (CI 77491, CI 77492, CI 77499). May Contain/Peut Contenir: Titanium Dioxide (CI 77891).

MINERAL WEAR LOOSE POWDER 
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69514-307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	12 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
LAUROYL LYSINE (UNII: 113171Q70B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ZINC STEARATE (UNII: H92E6QA4FV)
BORON NITRIDE (UNII: 2U4T60A6YD)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69514-307-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product	11/07/2022	12/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/07/2022	12/01/2023

Labeler - Markwins Beauty Brands (078890119)

Revised: 12/2023

Document Id: 0d99dccf-3a2b-818d-e063-6394a90a9a6a

34390-5

Set id: f383213c-dca0-bcd9-e053-2995a90a10dc

Version: 2

Effective Time: 20231228