ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion 
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 Smart Tone Broad-Spectrum Sunscreen SPF 50
National Drug Codes 42851-055-45, 42851-055-20

Drug Facts

Active Ingredients

Active IngredientsPurpose
Avobenzone 3% ...............Sunscreen
Homosalate 10%...............Sunscreen
Octisalate 5%...................Sunscreen
Octocrylene 10% ..............Sunscreen

Uses

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • Provides high protection against 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.
  • 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.

Other Information

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

Inactive Ingredients

Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, Mica, PEG-100 Stearate, Butylene Glycol, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Petasites Japonicus Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Melanin, Pentylene Glycol, Boron Nitride, Ethyl Ferulate, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate, Beta-Glucan, Ethylene Brassylate, Polymethyl
Methacrylate, Acrylates/Ammonium Methacrylate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Acrylates Crosspolymer-4, Panthenyl Triacetate, Glycerin, Aluminum Hydroxide, Simethicone, Ethyl Linoleate, Oleyl Alcohol,
Cetearyl Alcohol, PEG-8 Laurate, Steareth-2, Coco-Glucoside, Isostearic Acid, Sodium Hydroxide, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Fragrance, Titanium Dioxide, Iron Oxides.

Principal Display Panel

ZO® SKIN HEALTH

by ZEIN OBAGI MD

NDC 42851-055-45

Smart Tone Broad-Spectrum Sunscreen SPF 50

ZOX12 ®

ZO® Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50

Ultra-lightweight sunscreen with customizable color beads designed to blend into most skin tones. Provides broad-spectrum protection against UVA/UVB rays. Natural melanin helps shield skin from the aging effects of high-energy visible (HEV) light. Oxybenzone free.

ZOX12 ®

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 | 973380

ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYL FERULATE (UNII: 5B8915UELW)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
STEARETH-21 (UNII: 53J3F32P58)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
PETASITES JAPONICUS ROOT (UNII: 6F650HF10T)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER (UNII: T3064TZ75A)  
MICA (UNII: V8A1AW0880)  
ROSEMARY (UNII: IJ67X351P9)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
COCO GLUCOSIDE (UNII: ICS790225B)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ARGAN OIL (UNII: 4V59G5UW9X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
ALCOHOL (UNII: 3K9958V90M)  
STEARETH-2 (UNII: V56DFE46J5)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-055-451 in 1 CARTON06/01/2022
145 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:42851-055-201 in 1 CARTON06/01/2022
220 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2022
Labeler - ZO Skin Health, Inc. (826468527)

Revised: 4/2022
Document Id: dd09abaa-c8e1-5621-e053-2a95a90a6cbf
Set id: cda67d41-d063-4936-a6b9-23376304eb42
Version: 5
Effective Time: 20220419
 
ZO Skin Health, Inc.