Natural Defense Concealer

Natural Defense Concealer by

Drug Labeling and Warnings

Natural Defense Concealer by is a Otc medication manufactured, distributed, or labeled by Physicians Formula. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NATURAL DEFENSE CONCEALER SPF- octinoxate, titanium dioxide, zinc oxide cream 
Physicians Formula

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Natural Defense Concealer

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

NATURAL DEFENSE CONCEALER  SPF
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31645-220
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 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.9 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31645-220-02	1 in 1 CARTON	01/01/2021	03/01/2023
1	NDC: 31645-220-01	7 g 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 Drug	M020	01/01/2021	03/01/2023

Labeler - Physicians Formula (021261805)

Revised: 12/2023

Document Id: 0d88a01a-d4fd-6221-e063-6294a90ae6b2

34390-5

Set id: e64c9767-4168-84f4-e053-2a95a90a8c95

Version: 2

Effective Time: 20231227