ZO SKIN HEALTH SUNSCREEN PLUS BROAD-SPECTRUM SPF 40 MEDIUM- titanium dioxide and zinc oxide powder

ZO Skin Health Sunscreen Plus Broad-Spectrum SPF 40 Medium by

Drug Labeling and Warnings

ZO Skin Health Sunscreen Plus Broad-Spectrum SPF 40 Medium by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Paramount Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium Dioxide 24.4%	Sunscreen
Zinc Oxide 23.4%	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 damaged 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
• reapply: at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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, Polymethyl Methacrylate, HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Hydrogen Dimethicone, Dimethicone, Synthetic Fluorphlogopite, Simmondsia Chinensis (Jojoba) Seed Oil, Water, Ascorbic Acid, Tocopheryl Acetate, Retinyl Palmitate, Triethoxycaprylylsilane, Methicone, Tin Oxide, Melanin, Ethylhexylglycerin, Pentylene Glycol, Phenoxyethanol, Iron Oxides.

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 3 g Jar Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC: 42851-061-03

SUNSCREEN + POWDER
BROAD-SPECTRUM
SPF 40

ZOX12™

MEDIUM

Net Wt. 3 g / 0.10 Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH SUNSCREEN PLUS BROAD-SPECTRUM SPF 40 MEDIUM 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.732 mg  in 3 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.702 mg  in 3 g

Inactive Ingredients
Ingredient Name	Strength
Mica (UNII: V8A1AW0880)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
Hexamethylene Diisocyanate/Trimethylol Hexyllactone Crosspolymer (UNII: WB5K9Y35Y9)
Jojoba Butter (UNII: XIA46H803R)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
Dimethicone (UNII: 92RU3N3Y1O)
Jojoba Oil (UNII: 724GKU717M)
Water (UNII: 059QF0KO0R)
Ascorbic Acid (UNII: PQ6CK8PD0R)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Methicone (20 Cst) (UNII: 6777U11MKT)
Stannic Oxide (UNII: KM7N50LOS6)
Ethylhexylglycerin (UNII: 147D247K3P)
Pentylene Glycol (UNII: 50C1307PZG)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-061-03	1 in 1 CARTON	09/03/2019
1		3 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/03/2019

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Paramount Cosmetics		001321058	MANUFACTURE(42851-061) , PACK(42851-061)