ZO SKIN HEALTH SUNSCREEN PLUS BROAD-SPECTRUM SPF 40 LIGHT- titanium dioxide and zinc oxide powder 
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 Sunscreen + Powder Broad-Spectrum SPF 40 Light

Drug Facts

Active IngredientsPurpose
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.

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

PRINCIPAL DISPLAY PANEL - 3 g Jar Carton

ZO ® SKIN HEALTH
BY ZEIN OBAGI MD

NDC 42851-062-03

SUNSCREEN + POWDER
BROAD-SPECTRUM
SPF 40

ZOX 12

LIGHT

Net Wt. 3 g / 0.10 Oz.

PRINCIPAL DISPLAY PANEL - 3 g Jar Carton
ZO SKIN HEALTH SUNSCREEN PLUS BROAD-SPECTRUM SPF 40 LIGHT 
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.732 mg  in 3 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.702 mg  in 3 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-062-031 in 1 CARTON11/15/2019
13 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/15/201908/01/2022
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIBusiness Operations
Paramount Cosmetics001321058manufacture(42851-062) , pack(42851-062)

Revised: 3/2023
 
ZO Skin Health, Inc.