Label: ZO SKIN HEALTH AGGRESSIVE ANTI-AGING PROGRAM- titanium dioxide kit
-
Contains inactivated NDC Code(s)
NDC Code(s): 42851-168-15 - Packager: ZO Skin Health, Inc.
- Category: HUMAN OTC DRUG LABEL
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 June 18, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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) lotionProduct 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. 081239587 manufacture(42851-168) Establishment Name Address ID/FEI Business Operations Thibiant International, Inc. 083913913 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)