Label: ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR SKIN BRIGHTENING- titanium dioxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 42851-052-60, 42851-158-60 - 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 July 12, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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Uses
- Helps prevent 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
- Other information
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Directions
- For full protection, apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- For 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:
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- Limit time in the sun, especially from 10 a.m.- 2 p.m.
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- Wear long-sleeved shirts, pants, hats and sunglasses.
- Apply to all skin exposed to the sun.
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Inactive ingredients
Water, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclopentasiloxane, Phenyl Trimethicone, Styrene/Acrylates Copolymer, Pentylene Glycol, Dimethicone, Glycerin, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Polyacrylamide, Disodium EDTA, Phytosphingosine, Ceteareth-20, Cetearyl Alcohol, PEG-100 Stearate, Glyceryl Stearate, Sodium Dihydroxycetyl Phosphate, Hydrogenated Palm Glycerides, Melanin, Ethylhexylglycerin, Erythritol, Homarine HCL, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Nephelium Lappaceum Peel Extract, Glycine Soja (Soybean) extract, Silica, C13-14 Isoparaffin, Laureth-7.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR SKIN BRIGHTENING
titanium dioxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-158 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-158-60 1 in 1 CARTON 11/01/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE, WITH APPLICATOR 50 mL Part 2 1 TUBE 30 mL Part 3 1 BOTTLE, PUMP 30 mL Part 4 1 TUBE 60 g Part 1 of 4 ZO MEDICAL C-BRIGHT SERUM VITAMIN C
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Cyclomethicone 5 (UNII: 0THT5PCI0R) INGR Ascorbic Acid (UNII: PQ6CK8PD0R) INGR Dimethicone Crosspolymer (450000 Mpa.S At 12% In Cyclopentasiloxane) (UNII: UF7620L1W6) INGR Dimethicone (UNII: 92RU3N3Y1O) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR Bitter Orange Oil (UNII: 9TLV70SV6I) INGR Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) INGR Squalane (UNII: GW89575KF9) INGR .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) INGR Ubidecarenone (UNII: EJ27X76M46) INGR Limonene, (+)- (UNII: GFD7C86Q1W) INGR Citral (UNII: T7EU0O9VPP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 50 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 11/01/2015 Part 2 of 4 ZO MEDICAL BRIGHTALIVE NON-RETINOL SKIN BRIGHTENER
cleansing (cold creams, cleansing lotions, liquids, and pads) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR Cyclomethicone 5 (UNII: 0THT5PCI0R) INGR Caprylyl Trisiloxane (UNII: Q95M2P1KJL) INGR Glycerin (UNII: PDC6A3C0OX) INGR Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) INGR Alpha-Arbutin (UNII: 72VUP07IT5) INGR Bellis Perennis Flower (UNII: 26I94X9A1K) INGR Glyceryl Monostearate (UNII: 230OU9XXE4) INGR PEG-100 Stearate (UNII: YD01N1999R) INGR Cetyl Alcohol (UNII: 936JST6JCN) INGR Nonapeptide-1 (UNII: 64W45420K5) INGR Dimethylmethoxy Chromanyl Palmitate (UNII: 5G222ZDK7U) INGR Ubidecarenone (UNII: EJ27X76M46) INGR Hexylresorcinol (UNII: R9QTB5E82N) INGR Glycyrrhiza Glabra (UNII: 2788Z9758H) INGR Sunflower Oil (UNII: 3W1JG795YI) INGR Rosemary (UNII: IJ67X351P9) INGR Olea Europaea Leaf (UNII: MJ95C3OH47) INGR Stachys Officinalis Flowering Top (UNII: D7A759WU38) INGR Maltodextrin (UNII: 7CVR7L4A2D) INGR Lecithin, Sunflower (UNII: 834K0WOS5G) INGR Soy Isoflavones (UNII: 71B37NR06D) INGR Polysorbate 80 (UNII: 6OZP39ZG8H) INGR Alcohol (UNII: 3K9958V90M) INGR Ascorbyl Glucoside (UNII: 2V52R0NHXW) INGR Zinc Pidolate (UNII: C32PQ86DH4) INGR Ascorbic Acid (UNII: PQ6CK8PD0R) INGR N-Acetylglucosamine (UNII: V956696549) INGR Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N) INGR Sodium Oleate (UNII: 399SL044HN) INGR Butylene Glycol (UNII: 3XUS85K0RA) INGR N-Acetyltyrosine (UNII: DA8G610ZO5) INGR Proline (UNII: 9DLQ4CIU6V) INGR Adenosine Triphosphate (UNII: 8L70Q75FXE) INGR Papain (UNII: A236A06Y32) INGR Carboxypolymethylene (UNII: 0A5MM307FC) INGR 1,2-Hexanediol (UNII: TR046Y3K1G) INGR Sodium Alginate (UNII: C269C4G2ZQ) INGR Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11) INGR .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) INGR Vitamin A Palmitate (UNII: 1D1K0N0VVC) INGR Ascorbyl Palmitate (UNII: QN83US2B0N) INGR Sodium Sulfite (UNII: VTK01UQK3G) INGR Polyisobutylene (1000 MW) (UNII: 5XB3A63Y52) INGR Polysorbate 20 (UNII: 7T1F30V5YH) INGR PEG-12 Dimethicone/PPG-20 Crosspolymer (UNII: 965K72OQXO) INGR Dextran 1 (UNII: I8LHQ0D645) INGR Edetate Disodium (UNII: 7FLD91C86K) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR Caprylyl Glycol (UNII: 00YIU5438U) INGR Chlorphenesin (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 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 Cosmetic 11/01/2015 Part 3 of 4 ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE
cleansing (cold creams, cleansing lotions, liquids, and pads) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR Cetearyl Isononanoate (UNII: P5O01U99NI) INGR Cyclomethicone 5 (UNII: 0THT5PCI0R) INGR Cyclomethicone 6 (UNII: XHK3U310BA) INGR Pentylene Glycol (UNII: 50C1307PZG) INGR Cetostearyl Alcohol (UNII: 2DMT128M1S) INGR Glycerin (UNII: PDC6A3C0OX) INGR Steareth-20 (UNII: L0Q8IK9E08) INGR Carboxypolymethylene (UNII: 0A5MM307FC) INGR C14-22 Alcohols (UNII: B1K89384RJ) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR Cetearyl Glucoside (UNII: 09FUA47KNA) INGR Polysorbate 20 (UNII: 7T1F30V5YH) INGR Butylene Glycol (UNII: 3XUS85K0RA) INGR Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) INGR Sodium Hydroxide (UNII: 55X04QC32I) INGR Caprylyl Glycol (UNII: 00YIU5438U) INGR C12-20 Alkyl Glucoside (UNII: K67N5Z1RUA) INGR Ethylhexylglycerin (UNII: 147D247K3P) INGR Lactose, Unspecified Form (UNII: J2B2A4N98G) INGR Edetate Disodium (UNII: 7FLD91C86K) INGR Powdered Cellulose (UNII: SMD1X3XO9M) INGR Hexylene Glycol (UNII: KEH0A3F75J) INGR Potassium Sorbate (UNII: 1VPU26JZZ4) INGR 1,2-Hexanediol (UNII: TR046Y3K1G) INGR Methylparaben (UNII: A2I8C7HI9T) INGR Lecithin, Sunflower (UNII: 834K0WOS5G) INGR Hypromelloses (UNII: 3NXW29V3WO) INGR Sorbitol (UNII: 506T60A25R) INGR Edetic Acid (UNII: 9G34HU7RV0) INGR Benzoic Acid (UNII: 8SKN0B0MIM) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Arabidopsis Thaliana (UNII: AI3L60HQ81) INGR Retinol (UNII: G2SH0XKK91) INGR Vitamin A Palmitate (UNII: 1D1K0N0VVC) INGR .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) INGR Orange Oil (UNII: AKN3KSD11B) INGR Lemon Oil (UNII: I9GRO824LL) INGR Mandarin Oil (UNII: NJO720F72R) INGR Peppermint Oil (UNII: AV092KU4JH) INGR Mimosa Tenuiflora Bark (UNII: 515MQE449I) INGR Tocopherol (UNII: R0ZB2556P8) INGR Limonene, (+)- (UNII: GFD7C86Q1W) INGR Ultramarine Blue (UNII: I39WR998BI) INGR Ext. D&C Violet No. 2 (UNII: G5UX3K0728) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 11/01/2015 Part 4 of 4 ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50
titanium dioxide lotionProduct Information Item Code (Source) NDC:42851-052 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.08 g in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Stearic Acid (UNII: 4ELV7Z65AP) Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 MPA.S) (UNII: RLA2U05Z4Q) Cyclomethicone 5 (UNII: 0THT5PCI0R) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Pentylene Glycol (UNII: 50C1307PZG) Dimethicone (UNII: 92RU3N3Y1O) Glycerin (UNII: PDC6A3C0OX) Isodecyl Neopentanoate (UNII: W60VYE24XC) Diisopropyl Sebacate (UNII: J8T3X564IH) Lauryl Lactate (UNII: G5SU0BFK7O) Edetate Disodium (UNII: 7FLD91C86K) Phytosphingosine (UNII: GIN46U9Q2Q) Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY) Cetostearyl Alcohol (UNII: 2DMT128M1S) PEG-100 Stearate (UNII: YD01N1999R) Glyceryl Monostearate (UNII: 230OU9XXE4) Sodium Dihydroxycetyl Phosphate (UNII: YWI33EV595) Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q) Melanin Synthetic (Tyrosine, Peroxide) (UNII: O0CV1RMR44) Ethylhexylglycerin (UNII: 147D247K3P) Erythritol (UNII: RA96B954X6) Homarine Hydrochloride (UNII: 8866LNG61N) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) Phenoxyethanol (UNII: HIE492ZZ3T) Caprylyl Glycol (UNII: 00YIU5438U) Chlorphenesin (UNII: I670DAL4SZ) Nephelium Lappaceum Fruit Rind (UNII: Y0513T90FO) Soybean (UNII: L7HT8F1ZOD) Silicon Dioxide (UNII: ETJ7Z6XBU4) C13-14 Isoparaffin (UNII: E4F12ROE70) Laureth-7 (UNII: Z95S6G8201) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-052-60 60 g 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 11/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/01/2015 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Milbar Laboratories, Inc. 195556790 MANUFACTURE(42851-158) Establishment Name Address ID/FEI Business Operations G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(42851-158) Establishment Name Address ID/FEI Business Operations PakLab 790530976 MANUFACTURE(42851-158) Establishment Name Address ID/FEI Business Operations Thibiant International, Inc. 083913913 MANUFACTURE(42851-158)
