ZO SKIN HEALTH AGGRESSIVE ANTI-AGING PROGRAM- titanium dioxide kit
ZO SKIN HEALTH Aggressive Anti-Aging Program by
Drug Labeling and Warnings
ZO SKIN HEALTH Aggressive Anti-Aging Program by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Lifetech Resources, LLC., Thibiant International, Inc., DIAMOND WIPES INTERNATIONAL INC, PakLab. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
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
-
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
-
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
-
Inactive ingredients
Aluminum Hydroxide, Aqua/Water/Eau, Ascorbic Acid, Behenyl Behenate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium Uridine Phosphate, Ethyl Ferulate, Ethylhexylglycerin, Glycerin, Glycine Soja Extract, Helianthus Annuus Seed Oil, Hexyl Laurate, Iron Oxides, Melanin, Myristoyl Pentapeptide-8, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Pentylene Glycol, Phenoxyethanol, Phenyl Trimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polyglyceryl-4 Isostearate, Polyglyceryl-5 Trioleate, Polymethyl Methacrylate, Retinyl Palmitate, Rosmarinus Officinalis Leaf Extract, Squalane, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Triethoxycaprylylsilane.
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - Kit Carton
ZO® SKIN HEALTH
BY ZEIN OBAGI MDAGGRESSIVE ANTI-AGING PROGRAM
NDC: 42851-168-15HYDRATING CLEANSER 60 mL / 2 Fl. Oz. EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz.
COMPLEXION RENEWAL PADS 30 Pads DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.
ADVANCED RADICAL NIGHT REPAIR 30 mL / 1 Fl. Oz. RENEWAL CRÈME 50 mL / 1.7 Fl. Oz.
SUNSCREEN + PRIMER SPF 30 15 mL / 0.5 Fl. Oz.
-
INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH AGGRESSIVE ANTI-AGING PROGRAM
titanium dioxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 42851-168 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 42851-168-15 1 in 1 CARTON 11/01/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 60 mL Part 2 1 JAR 16.2 g Part 3 1 BOTTLE, GLASS 30 Part 4 1 BOTTLE, PUMP 30 mL Part 5 1 TUBE, WITH APPLICATOR 30 mL Part 6 1 JAR 50 mL Part 7 1 BOTTLE, PUMP 15 mL Part 1 of 7 ZO SKIN HEALTH HYDRATING CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR Sodium Cocoyl Isethionate (UNII: 518XTE8493) INGR Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G) INGR Glycerin (UNII: PDC6A3C0OX) INGR Glyceryl Monostearate (UNII: 230OU9XXE4) INGR PEG-100 Stearate (UNII: YD01N1999R) INGR Stearic Acid (UNII: 4ELV7Z65AP) INGR Disodium Cocoamphodiacetate (UNII: 18L9G3U51M) INGR Glycol Distearate (UNII: 13W7MDN21W) INGR Palmitic Acid (UNII: 2V16EO95H1) INGR Cetyl Alcohol (UNII: 936JST6JCN) INGR Panthenol (UNII: WV9CM0O67Z) INGR Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) INGR Urea (UNII: 8W8T17847W) INGR Hyaluronate Sodium (UNII: YSE9PPT4TH) INGR Trehalose (UNII: B8WCK70T7I) INGR Polyquaternium-51 (2-Methacryloyloxyethyl Phosphorylcholine/N-Butyl Methacrylate; 3:7) (UNII: EL9825H96J) INGR Triacetin (UNII: XHX3C3X673) INGR Limonene, (+)- (UNII: GFD7C86Q1W) INGR Linalool, (+/-)- (UNII: D81QY6I88E) INGR Sodium Hydroxide (UNII: 55X04QC32I) INGR Allantoin (UNII: 344S277G0Z) INGR Ethylhexylglycerin (UNII: 147D247K3P) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR D&C Red No. 33 (UNII: 9DBA0SBB0L) INGR FD&C Yellow No. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 60 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 11/01/2017 Part 2 of 7 ZO SKIN HEALTH EXFOLIATING POLISH
lotions, oils, powders, and creams creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Polyethylene Glycol 400 (UNII: B697894SGQ) INGR Sodium Bicarbonate (UNII: 8MDF5V39QO) INGR Magnesium Oxide (UNII: 3A3U0GI71G) INGR Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B) INGR Glycerin (UNII: PDC6A3C0OX) INGR Butylene Glycol (UNII: 3XUS85K0RA) INGR Oleth-20 (UNII: YTH167I2AG) INGR Trihydroxystearin (UNII: 06YD7896S3) INGR Glyceryl Monostearate (UNII: 230OU9XXE4) INGR PEG-100 Stearate (UNII: YD01N1999R) INGR Mineral Oil (UNII: T5L8T28FGP) INGR Water (UNII: 059QF0KO0R) INGR .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) INGR Tea Tree Oil (UNII: VIF565UC2G) INGR Soy Sterol (UNII: PL360EPO9J) INGR Limonene, (+)- (UNII: GFD7C86Q1W) INGR Linalool, (+/-)- (UNII: D81QY6I88E) INGR Ascorbyl Palmitate (UNII: QN83US2B0N) INGR Vitamin A Palmitate (UNII: 1D1K0N0VVC) INGR Stearyl Glycyrrhetinate (UNII: 3YYE6VJS0P) INGR Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) INGR Medium-Chain Triglycerides (UNII: C9H2L21V7U) INGR Linoleic Acid (UNII: 9KJL21T0QJ) INGR Lecithin, Soybean (UNII: 1DI56QDM62) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR D&C Green no. 6 (UNII: 4QP5U84YF7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 16.2 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 11/01/2017 Part 3 of 7 ZO SKIN HEALTH COMPLEXION RENEWAL PADS
cleansing (cold creams, cleansing lotions, liquids, and pads) patchProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR Propylene Glycol (UNII: 6DC9Q167V3) INGR Salicylic Acid (UNII: O414PZ4LPZ) INGR Urea (UNII: 8W8T17847W) INGR Glycolic Acid (UNII: 0WT12SX38S) INGR Pterocarpus Soyauxii Wood (UNII: 0V6QB4C61P) INGR Phellodendron Amurense Bark (UNII: PBG27B754G) INGR Barley (UNII: 5PWM7YLI7R) INGR Green Tea Leaf (UNII: W2ZU1RY8B0) INGR Plantago Lanceolata Leaf (UNII: 2YWL9J7EE8) INGR Crithmum Maritimum (UNII: J7IHY79BKY) INGR Butylene Glycol (UNII: 3XUS85K0RA) INGR Limonene, (+)- (UNII: GFD7C86Q1W) INGR Linalool, (+/-)- (UNII: D81QY6I88E) INGR .Alpha.-Hexylcinnamaldehyde (UNII: 7X6O37OK2I) INGR Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) INGR Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 11/01/2017 Part 4 of 7 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 Glycerin (UNII: PDC6A3C0OX) INGR Pentylene Glycol (UNII: 50C1307PZG) INGR Cetostearyl Alcohol (UNII: 2DMT128M1S) INGR Steareth-20 (UNII: L0Q8IK9E08) INGR C14-22 Alcohols (UNII: B1K89384RJ) INGR Cetearyl Glucoside (UNII: 09FUA47KNA) INGR Safflower Oil (UNII: 65UEH262IS) INGR Carboxypolymethylene (UNII: 0A5MM307FC) INGR C12-20 Alkyl Glucoside (UNII: K67N5Z1RUA) INGR Lactose, Unspecified Form (UNII: J2B2A4N98G) INGR Powdered Cellulose (UNII: SMD1X3XO9M) INGR Lecithin, Soybean (UNII: 1DI56QDM62) INGR Retinol (UNII: G2SH0XKK91) INGR 1,2-Hexanediol (UNII: TR046Y3K1G) INGR Hypromellose, Unspecified (UNII: 3NXW29V3WO) INGR Arabidopsis Thaliana (UNII: AI3L60HQ81) INGR Orange Oil (UNII: AKN3KSD11B) INGR Mandarin Oil (UNII: NJO720F72R) INGR Lemon Oil (UNII: I9GRO824LL) INGR Peppermint Oil (UNII: AV092KU4JH) INGR Mimosa Tenuiflora Bark (UNII: 515MQE449I) INGR Tangerine (UNII: KH3E3096OO) INGR Polysorbate 20 (UNII: 7T1F30V5YH) INGR Farnesol (UNII: EB41QIU6JL) INGR Limonene, (+)- (UNII: GFD7C86Q1W) INGR Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM) INGR Sodium Hydroxide (UNII: 55X04QC32I) INGR Palmitoyl Tripeptide-1 (UNII: RV743D216M) INGR Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) INGR Vitamin A Palmitate (UNII: 1D1K0N0VVC) INGR .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) INGR Caprylyl Glycol (UNII: 00YIU5438U) INGR Butylene Glycol (UNII: 3XUS85K0RA) INGR Hexylene Glycol (UNII: KEH0A3F75J) INGR Ethylhexylglycerin (UNII: 147D247K3P) INGR Phenoxyethanol (UNII: HIE492ZZ3T) 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 11/01/2017 Part 5 of 7 ZO SKIN HEALTH OSSENTIAL ADVANCED RADICAL NIGHT REPAIR
lotions, oils, powders, and creams lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Cyclomethicone 5 (UNII: 0THT5PCI0R) INGR Dimethicone Crosspolymer (450000 mpa.s at 12% in Cyclopentasiloxane) (UNII: UF7620L1W6) INGR Dimethicone (UNII: 92RU3N3Y1O) INGR Water (UNII: 059QF0KO0R) INGR Glycerin (UNII: PDC6A3C0OX) INGR Polysorbate 20 (UNII: 7T1F30V5YH) INGR Retinol (UNII: G2SH0XKK91) INGR Diisopropyl Adipate (UNII: P7E6YFV72X) INGR .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) INGR Butylated Hydroxytoluene (UNII: 1P9D0Z171K) INGR Caprylyl Glycol (UNII: 00YIU5438U) INGR Sodium Sulfite (UNII: VTK01UQK3G) INGR Ascorbyl Palmitate (UNII: QN83US2B0N) INGR Lecithin, Soybean (UNII: 1DI56QDM62) INGR Tocopherol (UNII: R0ZB2556P8) INGR Ascorbic Acid (UNII: PQ6CK8PD0R) INGR Plukenetia Volubilis Seed Oil (UNII: 8ED72Z8J1Z) INGR Sunflower Oil (UNII: 3W1JG795YI) INGR Zanthoxylum Bungeanum Fruit (UNII: 3CIP16A418) INGR Rosemary (UNII: IJ67X351P9) INGR Corn Oil (UNII: 8470G57WFM) INGR .Beta.-Carotene (UNII: 01YAE03M7J) INGR Citral (UNII: T7EU0O9VPP) INGR Geraniol (UNII: L837108USY) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR Chlorphenesin (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 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 11/01/2017 Part 6 of 7 ZO SKIN HEALTH OMMERSE RENEWAL CREME
lotions, oils, powders, and creams creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR Isopropyl Palmitate (UNII: 8CRQ2TH63M) INGR Isocetyl Stearate (UNII: 3RJ7186O9W) INGR Glycerin (UNII: PDC6A3C0OX) INGR Cetostearyl Alcohol (UNII: 2DMT128M1S) INGR Silicon Dioxide (UNII: ETJ7Z6XBU4) INGR Butylene Glycol (UNII: 3XUS85K0RA) INGR Dimethicone (UNII: 92RU3N3Y1O) INGR Ectoine (UNII: 7GXZ3858RY) INGR Steareth-21 (UNII: 53J3F32P58) INGR Laureth-23 (UNII: N72LMW566G) INGR Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO) INGR Polysorbate 60 (UNII: CAL22UVI4M) INGR Caprylyl Glycol (UNII: 00YIU5438U) INGR Steareth-2 (UNII: V56DFE46J5) INGR Edetate Sodium (UNII: MP1J8420LU) INGR Sodium Hydroxide (UNII: 55X04QC32I) INGR Ethylhexylglycerin (UNII: 147D247K3P) INGR Hexylene Glycol (UNII: KEH0A3F75J) INGR Hyaluronate Sodium (UNII: YSE9PPT4TH) INGR Polysorbate 20 (UNII: 7T1F30V5YH) INGR Retinol (UNII: G2SH0XKK91) INGR Coconut Oil (UNII: Q9L0O73W7L) INGR Hydrogenated Coco-Glycerides (UNII: XDD37N2GPR) INGR Tocopherol (UNII: R0ZB2556P8) INGR Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N) INGR Epilobium Angustifolium Flowering Top (UNII: 08H094218D) INGR Lecithin, Soybean (UNII: 1DI56QDM62) INGR Oat (UNII: Z6J799EAJK) INGR Gardenia Taitensis Flower (UNII: T0OCU8201Y) INGR Magnesium Ascorbyl Phosphate (UNII: 0R822556M5) INGR Ubidecarenone (UNII: EJ27X76M46) INGR Phenoxyethanol (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 50 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 11/01/2017 Part 7 of 7 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVAUVB PROTECTION
titanium dioxide lotionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 82 mg in 1 mL Inactive Ingredients Ingredient Name Strength Aluminum Hydroxide (UNII: 5QB0T2IUN0) Water (UNII: 059QF0KO0R) Ascorbic Acid (UNII: PQ6CK8PD0R) Behenyl Behenate (UNII: K8NU647RJ0) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Caprylyl Glycol (UNII: 00YIU5438U) Cetyl PEG/PPG-10/1 Dimethicone (HLB 2) (UNII: V2W71V8T0X) Chlorphenesin (UNII: I670DAL4SZ) Cyclomethicone 5 (UNII: 0THT5PCI0R) Dimethicone Crosspolymer (450000 MPA.S at 12% in cyclopentasiloxane) (UNII: UF7620L1W6) Dimethicone/Vinyl Dimethicone Crosspolymer (soft particle) (UNII: 9E4CO0W6C5) Dimethiconol (100000 CST) (UNII: OSA9UP217S) Uridine Monophosphate Disodium (UNII: KD8E20071T) Ethyl Ferulate (UNII: 5B8915UELW) Ethylhexylglycerin (UNII: 147D247K3P) Glycerin (UNII: PDC6A3C0OX) Sunflower Oil (UNII: 3W1JG795YI) Hexyl Laurate (UNII: 4CG9F9W01Q) Ferric Oxide Red (UNII: 1K09F3G675) Melanin Synthetic (Tyrosine, Peroxide) (UNII: O0CV1RMR44) Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS) Pentylene Glycol (UNII: 50C1307PZG) Phenoxyethanol (UNII: HIE492ZZ3T) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 MPA.S) (UNII: RLA2U05Z4Q) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Rosemary (UNII: IJ67X351P9) Squalane (UNII: GW89575KF9) Stearic Acid (UNII: 4ELV7Z65AP) Tocopherol (UNII: R0ZB2556P8) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Tribehenin (UNII: 8OC9U7TQZ0) Triethoxycaprylylsilane (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 15 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 OTC MONOGRAPH FINAL part352 11/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/01/2017 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Lifetech Resources, LLC. 622559110 MANUFACTURE(42851-168) Establishment Name Address ID/FEI Business Operations DIAMOND WIPES INTERNATIONAL INC 161104729 MANUFACTURE(42851-168) Establishment Name Address ID/FEI Business Operations PakLab 790530976 MANUFACTURE(42851-168) Establishment Name Address ID/FEI Business Operations Thibiant International, Inc. 083913913 MANUFACTURE(42851-168)
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