Label: ZO SKIN HEALTH SHEER FLUID BROAD-SPECTRUM SUNSCREEN SPF 50- zinc oxide lotion
- NDC Code(s): 42851-091-50
- 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 January 19, 2023
If you are a consumer or patient please visit this version.
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Drug Facts
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.
- 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
Dimethicone, Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Glycerin, Butylene Glycol, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polysorbate 20, Dimethicone Crosspolymer, Ethyl Ferulate, Triethoxycaprylylsilane, Bisabolol, Phenoxyethanol, Polymethyl Methacrylate, Caprylyl Glycol, Chlorphenesin, Sodium Chloride, Helianthus Annuus (Sunflower) Seed Oil, Sodium Citrate, Melanin, Pentylene Glycol, 1,2-Hexanediol, Ascorbic Acid, Retinyl Palmitate, Beta-Glucan, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ethylhexylglycerin, Iron Oxides.
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Principal Display Panel
ZO® Skin Health
by Zein Obagi MD
NDC 42851-091-50
Sheer Fluid Broad-Spectrum Sunscreen SPF 50
ZOX12®
50 mL / 1.7 Fl. Oz.
Mineral fluid sunscreen with a natural, bare-faced finish for all skin types. Antioxidant-rich formula defends skin against environmental aggressors. Provides broad-spectrum protection against UVA/UVB. Natural melanin shields skin from aging effects of high-energy visible (HEV) light.
Oxybenzone free.
Shake well before dispensing.
ZOX12®
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 | 916700
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH SHEER FLUID BROAD-SPECTRUM SUNSCREEN SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-091 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.225 g in 50 mL Inactive Ingredients Ingredient Name Strength ETHYL FERULATE (UNII: 5B8915UELW) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) PENTYLENE GLYCOL (UNII: 50C1307PZG) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) TOCOPHEROL (UNII: R0ZB2556P8) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) ARGAN OIL (UNII: 4V59G5UW9X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYSORBATE 20 (UNII: 7T1F30V5YH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) SUNFLOWER OIL (UNII: 3W1JG795YI) ASCORBIC ACID (UNII: PQ6CK8PD0R) WATER (UNII: 059QF0KO0R) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) LEVOMENOL (UNII: 24WE03BX2T) PHENOXYETHANOL (UNII: HIE492ZZ3T) ROSEMARY (UNII: IJ67X351P9) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHICONE (UNII: 92RU3N3Y1O) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) FERRIC OXIDE RED (UNII: 1K09F3G675) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-091-50 1 in 1 CARTON 04/01/2023 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 04/01/2023 Labeler - ZO Skin Health, Inc. (826468527)