Natural Defense Finishing Powder - Baja Fur

Natural Defense Finishing Powder by

Drug Labeling and Warnings

Natural Defense Finishing 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]

NATURAL DEFENSE FINISHING POWDER- octinoxate, oxybenzone, 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.

----------

Natural Defense Finishing Powder - Baja Fur

Active Ingredients

Octinoxate 5%

Oxybenzone 1.5%

Titanium Dioxide 3%

Zinc Oxide 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 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

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 direct sun

Inactive Ingredients

Mica, Calcium Aluminum Borosilicate, Boron Nitride, Tricaprylin, Lauroyl Lysine, Zinc Stearate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Fragrance/Parfum, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Ascorbyl Palmitate, Brassica Campestris/Aleurites Fordi Oil Copolymer, o-Cymen-5-ol, Tocopheryl Acetate, Water/Eau, Lecithin, Plankton Extract. May Contain/Peut Contenir: Iron Oxides (CI 77491, CI 77492, CI 77499)

Questions or comments?

call 1-800-227-0333 (USA only) or www.PhysiciansFormula.com

Package Label

NATURAL DEFENSE FINISHING POWDER 
octinoxate, oxybenzone, titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71413-219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.5 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DIMETHICONE 100 (UNII: RO266O364U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
MICA (UNII: V8A1AW0880)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71413-219-02	1 in 1 CARTON	01/01/2022
1	NDC: 71413-219-01	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2022

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

Establishment
Name	Address	ID/FEI	Business Operations
Baja Fur, S.A. de C.V.		821533098	manufacture(71413-219) , label(71413-219) , pack(71413-219)

Revised: 1/2022

Document Id: e9892386-5dda-092a-e053-2a95a90ad4c4

34390-5

Set id: e9892386-5ddb-092a-e053-2a95a90ad4c4

Version: 1

Effective Time: 20220101