Natural Defense Finishing Powder - 1711353, 1711354, 1711356; 69514-311

Natural Defense Finishing Powder by

Drug Labeling and Warnings

Natural Defense Finishing Powder by is a Otc medication manufactured, distributed, or labeled by Markwins Beauty Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NATURAL DEFENSE FINISHING POWDER- octinoxate, oxybenzone, titanium dioxide, zinc oxide powder 
Markwins Beauty Brands

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Natural Defense Finishing Powder - 1711353, 1711354, 1711356; 69514-311

Octinoxate 5%

Oxybenzone 1.5%

Titanium Dioxide 3%

Zinc Oxide 2%

Sunscreen

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

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.

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

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)

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69514-311
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 mg  in 1 g
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

Inactive Ingredients
Ingredient Name	Strength
ZINC STEARATE (UNII: H92E6QA4FV)
TRICAPRYLIN (UNII: 6P92858988)
BORON NITRIDE (UNII: 2U4T60A6YD)
LAUROYL LYSINE (UNII: 113171Q70B)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
.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: 69514-311-02	1 in 1 CARTON	01/23/2023	12/01/2023
1	NDC: 69514-311-01	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 Drug	M020	01/23/2023	12/01/2023

Labeler - Markwins Beauty Brands (078890119)

Revised: 12/2023

Document Id: 0d99dccf-3a2a-818d-e063-6394a90a9a6a

34390-5

Set id: f397c10d-7ee7-785e-e053-2995a90a44ac

Version: 2

Effective Time: 20231228