Natural Defense Foundation

Natural Defense Foundation by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

----------

Natural Defense Foundation

Active ingredients

Octinoxate 7.4%

Titanium Dioxide 5.8%

Zinc Oxide 1%

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, Dimethicone, Butylene Glycol, Propanediol, Cyclopentasiloxane, Glycerin, Polymethylsilsesquioxane, Diethylhexyl Succinate, Silica, Brassica Campestris/Aleurites Fordi Oil Copolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, PEG-10 Dimethicone, Calcium Aluminum Borosilicate, Methyl Methacrylate Crosspolymer, Aluminum Hydroxide, Sodium Chloride, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Fragrance/Parfum, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Hexylene Glycol, Hydrogen Dimethicone, Citric Acid, EDTA, Triethoxycaprylylsilane, PEG/PPG-18/18 Dimethicone, Dipropylene Glycol, BHT, Sodium Citrate, Tocopherol, Lecithin, 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 FOUNDATION  SPF
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31645-218
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.8 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.4 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
DIMETHICONE 100 (UNII: RO266O364U)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
EDETIC ACID (UNII: 9G34HU7RV0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31645-218-02	1 in 1 CARTON	01/01/2021	12/01/2023
1	NDC: 31645-218-01	30 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	12/01/2023

Labeler - Physicians Formula (021261805)

Revised: 12/2023

Document Id: 0d9a2158-63ad-acce-e063-6394a90adaff

34390-5

Set id: e5d41195-71e7-9ae8-e053-2995a90ab51e

Version: 2

Effective Time: 20231228