Mineral Wear Loose Powder 10948-10952, 11141; 71413-209

Mineral Wear Loose Powder by

Drug Labeling and Warnings

Mineral Wear Loose Powder by is a Otc medication manufactured, distributed, or labeled by Baja Fur, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MINERAL WEAR LOOSE POWDER SPF16- titanium dioxide, zinc oxide powder 
Baja Fur, S.A. de C.V.

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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Mineral Wear Loose Powder 10948-10952, 11141; 71413-209

Active ingredients

Titanium dioxide 12%

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 cause 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 a doctor if

rash occurs

Keep out of reach of children

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

Directions

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

Other information

Protect this product from excessive heat and sun

Inactive ingredients

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).

Questions or comments?

call toll-free 1-800-227-0333

Mineral Wear Loose Powder PDP

MINERAL WEAR LOOSE POWDER  SPF16
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71413-209
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: 71413-209-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2019

Labeler - Baja Fur, S.A. de C.V. (821533098)

Revised: 9/2021

Document Id: cd3e43b5-e8c7-0c42-e053-2a95a90a0863

34390-5

Set id: cd3e4387-a03e-8617-e053-2995a90a0f2e

Version: 1

Effective Time: 20210930