ZO SKIN HEALTH BROAD-SPECTRUM SUNSCREEN SPF 50- titanium dioxide, zinc oxide cream

ZO Skin Health Broad-Spectrum Sunscreen SPF 50 by

Drug Labeling and Warnings

ZO Skin Health Broad-Spectrum Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., LIFETECH RESOURCES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

• Active Ingredient: Purpose
• Titanium Dioxide 6.4%: Sunscreen
• Zinc Oxide 15.0%: Sunscreen

Uses

• Helps prevent sunburn

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 the product in this container from excessive heat and direct sun.

Inactive Ingredients

1,2-Hexanediol, Alumina, Aqua/Water/Eau, Ascorbic Acid, Beta-Glucan, Bisabolol, Butylene Glycol, Calcium Chloride, Cetyl PEG/PPG-10/1 Dimethicone, Cordyceps Militaris Mycelium Extract, Dimethicone, Dimethicone Crosspolymer, Erythritol, Ethylhexylglycerin, Glycerin, Glycine Soja (Soybean) Seed Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Hexyl Laurate, Homarine HCL, Iron Oxides, Lactobacillus Ferment, Melanin, PEG-10 Dimethicone, Pentylene Glycol, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethyl Methacrylate, Potassium Sorbate, Retinyl Palmitate, Scutellaria Baicalensis Root Extract, Silica, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Sodium Citrate, Squalane, Stearic Acid, Tocopheryl Acetate, Tribehenin.

Outer Package Label

ZO® Skin Health

by ZEIN OBAGI MD

NDC: 42851-064-04

BROAD-SPECTRUM
SUNSCREEN SPF 50
For sensitized skin

ZOX 12®

Lightweight, non-irritating mineral sunscreen for the most sensitive skin types and post-procedure skin. Provides broad-spectrum protection against UVA/UVB rays. Natural melanin shields skin from aging effects of high-energy visible (HEV) light. Oxybenzone free.

ZOX 12®

Engineered with our exclusive 12-hour, time-release ZOX12® complex, our sunscreens help shield the skin from harmful infrared (IR-A) rays.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618
Made in USA with US & imported materials
zoskinhealth.com

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH BROAD-SPECTRUM SUNSCREEN SPF 50 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.552 mg  in 118 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.7 mg  in 118 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALUMINUM OXIDE (UNII: LMI26O6933)
WATER (UNII: 059QF0KO0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ERYTHRITOL (UNII: RA96B954X6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
DIMETHICONE (UNII: 92RU3N3Y1O)
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SOLANUM ANOMALUM WHOLE (UNII: 7J95G4E8OY)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SCUTELLARIA LATERIFLORA TOP (UNII: C6CNB75R61)
STEARIC ACID (UNII: 4ELV7Z65AP)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEVOMENOL (UNII: 24WE03BX2T)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
TRIBEHENIN (UNII: 8OC9U7TQZ0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-064-04	1 in 1 CARTON	08/15/2022
1		118 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 final	part352	08/15/2022

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
LIFETECH RESOURCES LLC		622559110	manufacture(42851-064)