NDC | 42851-052-60, 42851-156-60 |
Set ID | b82ed5d1-166c-4437-8bc3-397d4a307765 |
Category | HUMAN OTC DRUG LABEL |
Packager | ZO Skin Health, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- 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
- Other information
-
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.
-
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.
- Apply to all skin exposed to the sun.
-
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
-
INGREDIENTS AND APPEARANCE
ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR RESTORING EVEN SKIN TONE
titanium dioxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-156 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-156-60 1 in 1 CARTON 06/01/2014 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 30 mL Part 2 1 TUBE 30 mL Part 3 1 TUBE 60 g Part 4 1 TUBE 30 mL Part 5 1 BOTTLE, PUMP 30 mL Part 1 of 5 RETAMAX ACTIVE VITAMIN A MICRO EMULSION
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 GLYCERIN (UNII: PDC6A3C0OX) INGR CYCLOMETHICONE 6 (UNII: XHK3U310BA) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR STEARETH-20 (UNII: L0Q8IK9E08) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR SUNFLOWER OIL (UNII: 3W1JG795YI) INGR RETINOL (UNII: G2SH0XKK91) INGR PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR 1,2-HEXANEDIOL (UNII: TR046Y3K1G) INGR APRICOT KERNEL OIL (UNII: 54JB35T06A) INGR CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) INGR BROCCOLI (UNII: UOI4FT57BZ) INGR POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR ASCORBYL PALMITATE (UNII: QN83US2B0N) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR HYDROLYZED SERICIN (ENZYMATIC; 2500 MW) (UNII: 02EMA6F96C) INGR SODIUM SULFITE (UNII: VTK01UQK3G) INGR SODIUM METABISULFITE (UNII: 4VON5FNS3C) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR CYCLOMETHICONE 4 (UNII: CZ227117JE) INGR STEARYL ALCOHOL (UNII: 2KR89I4H1Y) INGR SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) INGR MYRISTYL ALCOHOL (UNII: V42034O9PU) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR LINALYL ACETATE (UNII: 5K47SSQ51G) INGR CURDLAN (UNII: 6930DL209R) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) INGR PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) INGR ETHYL NICOTINATE (UNII: NIJ3H353YH) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Benzoic Acid (UNII: 8SKN0B0MIM) INGR CARVOMENTHONE (UNII: D5PYY1B83Q) INGR LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P) INGR .ALPHA.-OCIMENE, (3Z)- (UNII: LTP9229T5N) INGR 4-CARVOMENTHENOL (UNII: L65MV77ZG6) INGR TOCOPHEROL (UNII: R0ZB2556P8) 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 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/11/2012 Part 2 of 5 BRIGHTENEX SKIN BRIGHTENER AND CORRECTING, NON-HYDROQUINONE
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 GLYCERIN (UNII: PDC6A3C0OX) INGR ALMOND OIL (UNII: 66YXD4DKO9) INGR CYCLOMETHICONE 6 (UNII: XHK3U310BA) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR STEARETH-20 (UNII: L0Q8IK9E08) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR RETINOL (UNII: G2SH0XKK91) INGR CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR CYCLOMETHICONE 4 (UNII: CZ227117JE) INGR CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) INGR APRICOT KERNEL OIL (UNII: 54JB35T06A) INGR EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR ASCORBYL PALMITATE (UNII: QN83US2B0N) INGR GLUTATHIONE (UNII: GAN16C9B8O) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR N-ACETYLGLUCOSAMINE (UNII: V956696549) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR 1,2-HEXANEDIOL (UNII: TR046Y3K1G) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR SOY ISOFLAVONES (UNII: 71B37NR06D) INGR POLYSORBATE 61 (UNII: X9E1MY2JQG) INGR ALCOHOL (UNII: 3K9958V90M) INGR NYLON-12 (UNII: 446U8J075B) INGR SODIUM SULFITE (UNII: VTK01UQK3G) INGR SODIUM METABISULFITE (UNII: 4VON5FNS3C) INGR CORN OIL (UNII: 8470G57WFM) INGR .BETA.-CAROTENE (UNII: 01YAE03M7J) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR GLUCONOLACTONE (UNII: WQ29KQ9POT) INGR POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y) INGR SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) INGR LAVENDER OIL (UNII: ZBP1YXW0H8) INGR GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) 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 01/11/2012 Part 3 of 5 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) STEARIC ACID (UNII: 4ELV7Z65AP) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) EDETATE DISODIUM (UNII: 7FLD91C86K) PENTYLENE GLYCOL (UNII: 50C1307PZG) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) LAURYL LACTATE (UNII: G5SU0BFK7O) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) MELAMINE (UNII: N3GP2YSD88) ERYTHRITOL (UNII: RA96B954X6) HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N) NEPHELIUM LAPPACEUM FRUIT RIND (UNII: Y0513T90FO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 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 06/01/2013 Part 4 of 5 RESTORACALM SOOTHING RECOVERY
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 BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR ETHYLHEXYL PALMITATE (UNII: 2865993309) INGR JOJOBA BUTTER (UNII: XIA46H803R) INGR CURDLAN (UNII: 6930DL209R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) INGR ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) INGR ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) INGR ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) INGR DOCOSANOL (UNII: 9G1OE216XY) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR N-ACETYLTYROSINE (UNII: DA8G610ZO5) INGR HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR HYDROLYZED SERICIN (ENZYMATIC; 2500 MW) (UNII: 02EMA6F96C) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR SUNFLOWER OIL (UNII: 3W1JG795YI) INGR ETHYL FERULATE (UNII: 5B8915UELW) INGR POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH) INGR ROSEMARY (UNII: IJ67X351P9) INGR URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T) INGR SULFURYL FLUORIDE (UNII: 64B59K7U6Q) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR 1,2-HEXANEDIOL (UNII: TR046Y3K1G) INGR PROLINE (UNII: 9DLQ4CIU6V) INGR RETINOL (UNII: G2SH0XKK91) INGR POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR DEHYDROACETIC ACID (UNII: 2KAG279R6R) INGR ANGELICA SINENSIS ROOT (UNII: B66F4574UG) INGR ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) 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 01/11/2012 Part 5 of 5 OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA
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 RETINOL (UNII: G2SH0XKK91) INGR EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR STEARETH-20 (UNII: L0Q8IK9E08) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR JOJOBA BUTTER (UNII: XIA46H803R) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR CURDLAN (UNII: 6930DL209R) INGR LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) 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 ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) INGR C14-22 ALCOHOLS (UNII: B1K89384RJ) INGR CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) INGR C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) INGR POWDERED CELLULOSE (UNII: SMD1X3XO9M) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) INGR PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) INGR HYPROMELLOSES (UNII: 3NXW29V3WO) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR LIMONENE, (+/-)- (UNII: 9MC3I34447) 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 01/11/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 05/01/2014 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations THIBIANT INTERNATIONAL, INC. 083913913 MANUFACTURE(42851-156) Establishment Name Address ID/FEI Business Operations SANITOR CORPORATION 797472792 MANUFACTURE(42851-156) Establishment Name Address ID/FEI Business Operations Lifetech Resources 622559110 MANUFACTURE(42851-156) Establishment Name Address ID/FEI Business Operations PAKLAB 790530976 MANUFACTURE(42851-156)