ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion 
ZO Skin Health, Inc.

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Drug Facts

Active Ingredients

IngredientsPurpose
Avobenzone 3.0%.............Sunscreen
Homosalate 6.8%.............Sunscreen
Octisalate 5.0%................ Sunscreen
Octocrylene 10.0%................ 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 and as needed.
  • 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

  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Mica, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Petasites Japonicus Root Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Propylene Glycol Stearate, Melanin, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Beta-Glucan, Glycerin, Ethyl Linoleate, Oleyl Alcohol, Acrylates Crosspolymer-4, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Stearate, Panthenyl Triacetate, Cetearyl Alcohol, PEG-8 Laurate, Coco-Glucoside, Steareth-2, Polymethyl Methacrylate, Cellulose Acetate,Acrylates/Ammonium Methacrylate Copolymer, Simethicone, Disodium EDTA, Sodium Hydroxide, Ethyl Ferulate, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Ethylene Brassylate, Fragrance, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 77492, 77499).

US Smart Tone 45 mL Unit Carton

ZO® SKIN HEALTH

by ZEIN OBAGI MD

NDC 42851-096-45

Smart Tone Broad-Spectrum Sunscreen SPF 50

ZOX12 ®

45 mL / 1.5 Fl. Oz.

ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-096
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE68 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PEG-100 STEARATE (UNII: YD01N1999R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYL FERULATE (UNII: 5B8915UELW)  
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)  
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
MICA (UNII: V8A1AW0880)  
STEARETH-21 (UNII: 53J3F32P58)  
ROSEMARY (UNII: IJ67X351P9)  
PETASITES JAPONICUS ROOT (UNII: 6F650HF10T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCO-GLUCOSIDE (UNII: ICS790225B)  
STEARETH-2 (UNII: V56DFE46J5)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
POLYAMIDE-5 (UNII: UEM62QMW5F)  
ARGAN OIL (UNII: 4V59G5UW9X)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER (UNII: T3064TZ75A)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-096-201 in 1 CARTON04/19/2024
145 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:42851-096-451 in 1 CARTON04/19/2024
245 mL in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/19/2024
Labeler - ZO Skin Health, Inc. (826468527)

Revised: 4/2024
Document Id: 1560a6b6-8d4b-6942-e063-6294a90a4a44
Set id: 1560a6b6-8d4a-6942-e063-6294a90a4a44
Version: 1
Effective Time: 20240405
 
ZO Skin Health, Inc.