Natural Defense Concealer - Baja Fur

Natural Defense Concealer by

Drug Labeling and Warnings

Natural Defense Concealer 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 CONCEALER SPF- octinoxate, titanium dioxide, zinc oxide cream 
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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Natural Defense Concealer - Baja Fur

Active ingredients

Octinoxate 4.9%

Titanium Dioxide 5%

Zinc Oxide 2.3%

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 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

Water/Eau, Cyclopentasiloxane, Ethyl Macadamiate, Polymethylsilsesquioxane, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone, Silica, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Tribehenin, Brassica Campestris/Aleurites Fordi Oil Copolymer, Calcium Aluminum Borosilicate, Glycerin, Stearic Acid, Aluminum Hydroxide, Dimethicone/PEG-10/15 Crosspolymer, Disteardimonium Hectorite, Lecithin, Dimethicone Crosspolymer, Polysorbate 60, Sodium Chloride, Phenoxyethanol, Triethoxycaprylylsilane, Propylene Carbonate, Caprylyl Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ethylhexylglycerin, Hexylene Glycol, Alumina, PEG/PPG-18/18 Dimethicone, Hydrogen Dimethicone, Fragrance/Parfum, Hexyl Laurate, Polyglyceryl-4 Isostearate, Tetrasodium EDTA, Sorbitan Isostearate, Dipropylene Glycol, BHT, Sodium Citrate, Tocopherol, Plankton Extract. May Contain/Peut Contenir: Iron Oxides (CI 77491, CI 77492, CI 77499), Mica, Titanium Dioxide (CI 77891).

Questions or comments?

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

Package label. PDP

Package Label PDP

NATURAL DEFENSE CONCEALER  SPF
octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71413-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.9 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE 100 (UNII: RO266O364U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MICA (UNII: V8A1AW0880)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GLYCERIN (UNII: PDC6A3C0OX)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71413-220-021 in 1 CARTON01/01/2022
1NDC: 71413-220-017 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2022
Labeler - Baja Fur, S.A. de C.V. (821533098)

Revised: 1/2022
 

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