NYDG DISCOVERY SET (ZINC OXIDE) KIT [VAN LAERE LLC]

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NYDG DISCOVERY SET (ZINC OXIDE) KIT [VAN LAERE LLC]
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NDC 71994-008-01
Set ID 186c094e-e14b-474e-b7b0-a42908660995
Category HUMAN OTC DRUG LABEL
Packager Van Laere LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 17.5%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • Retains SPF after 80 minutes of activity in the water or perspiring
  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away

  • Directions

    Apply generously 15 minutes before sun exposure.

    Reapply:

    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

    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 10am–2pm
      • wear long-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age: Ask a doctor
  • Other information

    Protect this product from excessive heat and direct sun. Report a serious adverse event reaction to: van laere llc. 119 Fifth Avenue, New York, NY 10003

  • Inactive Ingredients

    Water (Aqua), Isononyl Isononanoate, Caprylic/Capric Triglyceride, Dimethicone, Hexylene Glycol, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Argania Spinosa Kernel Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copoly Polyglyceryl-4 Isostearate, Tocopheryl Acetate, Polyhydroxystearic Acid, Squalane, Polyglyceryl-3-Poyricinoleate, Phenoxyethanol, Lecithin, Sodium Chloride, Isostearic Acid, Hexyl Laurate Ethylhexylglycerin, Bisabolol, Caprylyl Glycol, Polysorbate 60, Chlorphenesin, Disodium EDTA

  • SPL UNCLASSIFIED SECTION

    Distributed by van laere llc, New York, NY10003, USA

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    N
    Y
    NEW YORK
    DERMATOLOGY
    GROUP
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    G

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    NYDG DISCOVERY SET 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71994-008
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71994-008-011 in 1 CARTON05/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 30 mL
    Part 21 BOTTLE, PLASTIC 30 mL
    Part 31 JAR 15 mL
    Part 41 TUBE 5 mL
    Part 1 of 4
    CHEM-FREE ACTIVE DEFENSE SPF 30 
    zinc oxide cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide175 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Squalane (UNII: GW89575KF9)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Isostearic Acid (UNII: X33R8U0062)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Hexyl Laurate (UNII: 4CG9F9W01Q)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Farnesol (UNII: EB41QIU6JL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/01/2018
    Part 2 of 4
    LUMINIZING SKIN ESSENCE 
    moisturizing gel
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRTRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    INGRGLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRCAFFEINE (UNII: 3G6A5W338E)  
    INGRSODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRROSEMARY OIL (UNII: 8LGU7VM393)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRMETHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    INGRPOLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    INGRPPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    INGRMENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    INGRLACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGREPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    INGRSIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    INGRPSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    INGRBEET (UNII: N487KM8COK)  
    INGRCORN SYRUP (UNII: 9G5L16BK6N)  
    INGRLACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    INGRP-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    INGRLEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic05/01/2018
    Part 3 of 4
    FORMULA 119 
    moisturizing cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRDimethicone (UNII: 92RU3N3Y1O)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRPPG-3 Benzyl Ether Myristate (UNII: 8075L58MKO)  
    INGRIsosorbide Dicaprylate (UNII: 0IK29C4889)  
    INGRPhenyl Trimethicone (UNII: DR0K5NOJ4R)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRTrehalose (UNII: B8WCK70T7I)  
    INGRDIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPEG-100 Stearate (UNII: YD01N1999R)  
    INGRPolysorbate 60 (UNII: CAL22UVI4M)  
    INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    INGRButylene Glycol (UNII: 3XUS85K0RA)  
    INGRPhenoxyethanol (UNII: HIE492ZZ3T)  
    INGRDIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    INGRChlorphenesin (UNII: I670DAL4SZ)  
    INGRCeteth-10 Phosphate (UNII: 4E05O5N49G)  
    INGRDIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    INGRTocopherol (UNII: R0ZB2556P8)  
    INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
    INGRCHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    INGREthylhexylglycerin (UNII: 147D247K3P)  
    INGRPotassium Sorbate (UNII: 1VPU26JZZ4)  
    INGRSodium Benzoate (UNII: OJ245FE5EU)  
    INGRSodium Hydroxide (UNII: 55X04QC32I)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRTetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    INGRXanthan Gum (UNII: TTV12P4NEE)  
    INGRDEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    INGRRICE GERM (UNII: 7N2B70SFEZ)  
    INGRPalmitoyl Tripeptide-5 (UNII: 2A3916MQHO)  
    INGRSAGE OIL (UNII: U27K0H1H2O)  
    INGRSea Salt (UNII: 87GE52P74G)  
    INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    INGRMATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    INGRGINKGO (UNII: 19FUJ2C58T)  
    INGRHYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    INGRASIAN GINSENG (UNII: CUQ3A77YXI)  
    INGRVITIS VINIFERA SEED (UNII: C34U15ICXA)  
    INGRGERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRPALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073)  
    INGRCHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    INGRPALMITOYLLYSYLVALYLDIAMINOBUTYRIC ACID TRIFLUOROACETATE (UNII: 79390Q4BYV)  
    INGRMagnesium Chloride (UNII: 02F3473H9O)  
    INGRPALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic05/01/2018
    Part 4 of 4
    RE-CONTOUR EYE 
    eye lotion gel
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRHYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INGRLOCUST BEAN GUM (UNII: V4716MY704)  
    INGRHYDROLYZED CASEIN (ENZYMATIC; 1000 MW) (UNII: M93H91U80R)  
    INGRPhenoxyethanol (UNII: HIE492ZZ3T)  
    INGRHYPNEA MUSCIFORMIS (UNII: W6FF9R1FJV)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGRSARGASSUM FILIPENDULA (UNII: 55P66J5H7N)  
    INGRSORBITOL (UNII: 506T60A25R)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRMETHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    INGRPOLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    INGRPPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    INGRPropylene Glycol (UNII: 6DC9Q167V3)  
    INGRHORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    INGRBORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
    INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    INGRCUCUMBER (UNII: YY7C30VXJT)  
    INGRSodium Hydroxide (UNII: 55X04QC32I)  
    INGREthylhexylglycerin (UNII: 147D247K3P)  
    INGRGELIDIELLA ACEROSA (UNII: T91K54D6M1)  
    INGRAllantoin (UNII: 344S277G0Z)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGREPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    INGRGLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    INGRMORUS ALBA BARK (UNII: 7O71A48NDP)  
    INGRSASSAFRAS ALBIDUM ROOT BARK (UNII: XC5UMP9I5F)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRCHAMOMILE (UNII: FGL3685T2X)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRCLADANTHUS MIXTUS WHOLE (UNII: C7WCT2G709)  
    INGRSodium Lactate (UNII: TU7HW0W0QT)  
    INGRSACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    INGRArginine (UNII: 94ZLA3W45F)  
    INGRASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)  
    INGRAspartic Acid (UNII: 30KYC7MIAI)  
    INGRPIDOLIC ACID (UNII: SZB83O1W42)  
    INGRGlycine (UNII: TE7660XO1C)  
    INGRAlanine (UNII: OF5P57N2ZX)  
    INGRSerine (UNII: 452VLY9402)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    INGRValine (UNII: HG18B9YRS7)  
    INGRIsoleucine (UNII: 04Y7590D77)  
    INGRProline (UNII: 9DLQ4CIU6V)  
    INGRThreonine (UNII: 2ZD004190S)  
    INGRHistidine (UNII: 4QD397987E)  
    INGRPhenylalanine (UNII: 47E5O17Y3R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic05/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/01/2018
    Labeler - Van Laere LLC (081010441)
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