ZO SKIN HEALTH BROAD-SPECTRUM SUNSCREEN SPF 50- titanium dioxide, zinc oxide cream 
ZO Skin Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ZO® Skin Health Broad-Spectrum Sunscreen SPF 50
42851-064

Drug Facts

Active Ingredients

Active IngredientPurpose
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

Broad-Spectrum Sunscreen SPF 50

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

ZO SKIN HEALTH BROAD-SPECTRUM SUNSCREEN SPF 50 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.552 mg  in 118 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.7 mg  in 118 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-064-041 in 1 CARTON08/15/2022
1118 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/15/2022
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIBusiness Operations
LIFETECH RESOURCES LLC622559110manufacture(42851-064)

Revised: 9/2022
Document Id: e81c7511-8433-1d43-e053-2a95a90a008e
Set id: d817f80b-a998-b67e-e053-2995a90a1971
Version: 3
Effective Time: 20220907
 
ZO Skin Health, Inc.