Label: ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 42851-096-20, 42851-096-45
- Packager: ZO Skin Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 5, 2024
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Drug Facts
Active Ingredients
Ingredients Purpose 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
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).
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-096 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 68 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-096-20 1 in 1 CARTON 04/19/2024 1 45 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:42851-096-45 1 in 1 CARTON 04/19/2024 2 45 mL 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 Drug M020 04/19/2024 Labeler - ZO Skin Health, Inc. (826468527)
