Label: ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 42851-055-20, 42851-055-45
- Packager: ZO Skin Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 19, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Drug Facts
Active Ingredients
Active Ingredients Purpose 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
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.
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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.
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 ®
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 -
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:42851-055 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-055-45 1 in 1 CARTON 06/01/2022 1 45 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:42851-055-20 1 in 1 CARTON 06/01/2022 2 20 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 final part352 06/01/2022 Labeler - ZO Skin Health, Inc. (826468527)