Label: NYDG TRAVEL ESSENTIALS- zinc oxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 71994-009-01 - Packager: Van Laere LLC
- 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 March 8, 2018
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
- Uses
- Warnings
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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
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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
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
NYDG TRAVEL ESSENTIALS
zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71994-009 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71994-009-01 1 in 1 CARTON 05/01/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 30 mL Part 2 1 BOTTLE, PLASTIC 30 mL Part 3 1 JAR 15 mL Part 4 1 TUBE 5 mL Part 5 1 TUBE 30 mL Part 6 1 BOTTLE 15 mL Part 1 of 6 CHEM-FREE ACTIVE DEFENSE SPF 30
zinc oxide creamProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 175 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 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 OTC monograph final part352 05/01/2018 Part 2 of 6 LUMINIZING SKIN ESSENCE
moisturizing gelProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR WATER (UNII: 059QF0KO0R) INGR TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) INGR GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) INGR ALLANTOIN (UNII: 344S277G0Z) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR CAFFEINE (UNII: 3G6A5W338E) INGR SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR ROSEMARY OIL (UNII: 8LGU7VM393) INGR 1,2-HEXANEDIOL (UNII: TR046Y3K1G) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR METHYL GLUCETH-20 (UNII: J3QD0LD11P) INGR POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) INGR PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) INGR MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) INGR LACTOBACILLUS REUTERI (UNII: 9913I24QEE) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) INGR SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) INGR PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) INGR BEET (UNII: N487KM8COK) INGR CORN SYRUP (UNII: 9G5L16BK6N) INGR LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) INGR P-ANISIC ACID (UNII: 4SB6Y7DMM3) INGR LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 05/01/2018 Part 3 of 6 FORMULA 119
moisturizing creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR Glycerin (UNII: PDC6A3C0OX) INGR Dimethicone (UNII: 92RU3N3Y1O) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR PPG-3 Benzyl Ether Myristate (UNII: 8075L58MKO) INGR Isosorbide Dicaprylate (UNII: 0IK29C4889) INGR Phenyl Trimethicone (UNII: DR0K5NOJ4R) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR Trehalose (UNII: B8WCK70T7I) INGR DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 Stearate (UNII: YD01N1999R) INGR Polysorbate 60 (UNII: CAL22UVI4M) INGR CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) INGR Butylene Glycol (UNII: 3XUS85K0RA) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) INGR Chlorphenesin (UNII: I670DAL4SZ) INGR Ceteth-10 Phosphate (UNII: 4E05O5N49G) INGR DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) INGR Tocopherol (UNII: R0ZB2556P8) INGR LAVENDER OIL (UNII: ZBP1YXW0H8) INGR CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) INGR Ethylhexylglycerin (UNII: 147D247K3P) INGR Potassium Sorbate (UNII: 1VPU26JZZ4) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Sodium Hydroxide (UNII: 55X04QC32I) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) INGR Xanthan Gum (UNII: TTV12P4NEE) INGR DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) INGR RICE GERM (UNII: 7N2B70SFEZ) INGR Palmitoyl Tripeptide-5 (UNII: 2A3916MQHO) INGR SAGE OIL (UNII: U27K0H1H2O) INGR Sea Salt (UNII: 87GE52P74G) INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0) INGR MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) INGR GINKGO (UNII: 19FUJ2C58T) INGR HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK) INGR ASIAN GINSENG (UNII: CUQ3A77YXI) INGR VITIS VINIFERA SEED (UNII: C34U15ICXA) INGR GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073) INGR CHLORELLA VULGARIS (UNII: RYQ4R60M02) INGR PALMITOYLLYSYLVALYLDIAMINOBUTYRIC ACID TRIFLUOROACETATE (UNII: 79390Q4BYV) INGR Magnesium Chloride (UNII: 02F3473H9O) INGR PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 15 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 05/01/2018 Part 4 of 6 RE-CONTOUR EYE
eye lotion gelProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) INGR LOCUST BEAN GUM (UNII: V4716MY704) INGR HYDROLYZED CASEIN (ENZYMATIC; 1000 MW) (UNII: M93H91U80R) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR HYPNEA MUSCIFORMIS (UNII: W6FF9R1FJV) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR SARGASSUM FILIPENDULA (UNII: 55P66J5H7N) INGR SORBITOL (UNII: 506T60A25R) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR METHYLPROPANEDIOL (UNII: N8F53B3R4R) INGR POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) INGR PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) INGR Propylene Glycol (UNII: 6DC9Q167V3) INGR HORSE CHESTNUT (UNII: 3C18L6RJAZ) INGR BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0) INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0) INGR CUCUMBER (UNII: YY7C30VXJT) INGR Sodium Hydroxide (UNII: 55X04QC32I) INGR Ethylhexylglycerin (UNII: 147D247K3P) INGR GELIDIELLA ACEROSA (UNII: T91K54D6M1) INGR Allantoin (UNII: 344S277G0Z) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) INGR GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) INGR MORUS ALBA BARK (UNII: 7O71A48NDP) INGR SASSAFRAS ALBIDUM ROOT BARK (UNII: XC5UMP9I5F) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR CHAMOMILE (UNII: FGL3685T2X) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR CLADANTHUS MIXTUS WHOLE (UNII: C7WCT2G709) INGR Sodium Lactate (UNII: TU7HW0W0QT) INGR SACCHAROMYCES LYSATE (UNII: R85W246Z1C) INGR Arginine (UNII: 94ZLA3W45F) INGR ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC) INGR Aspartic Acid (UNII: 30KYC7MIAI) INGR PIDOLIC ACID (UNII: SZB83O1W42) INGR Glycine (UNII: TE7660XO1C) INGR Alanine (UNII: OF5P57N2ZX) INGR Serine (UNII: 452VLY9402) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR SODIUM METABISULFITE (UNII: 4VON5FNS3C) INGR Valine (UNII: HG18B9YRS7) INGR Isoleucine (UNII: 04Y7590D77) INGR Proline (UNII: 9DLQ4CIU6V) INGR Threonine (UNII: 2ZD004190S) INGR Histidine (UNII: 4QD397987E) INGR Phenylalanine (UNII: 47E5O17Y3R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 5 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 05/01/2018 Part 5 of 6 COLLOIDAL OATMEAL 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 Polyglyceryl-3 Laurate (UNII: Y9ZSR39D0E) INGR Sucrose Cocoate (UNII: 3H18P0UK73) INGR Glycerin (UNII: PDC6A3C0OX) INGR Cocamidopropyl Betaine (UNII: 5OCF3O11KX) INGR Coconut Acid (UNII: 40U37V505D) INGR Castoryl Maleate (UNII: V5B97ZYP2F) INGR OATMEAL (UNII: 8PI54V663Y) INGR SOYBEAN OIL (UNII: 241ATL177A) INGR Palmitic Acid (UNII: 2V16EO95H1) INGR Sodium Lauroyl Sarcosinate (UNII: 632GS99618) INGR Sodium Isethionate (UNII: 3R36J71C17) INGR Ethylhexylglycerin (UNII: 147D247K3P) INGR Potassium Sorbate (UNII: 1VPU26JZZ4) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR BITTER ORANGE OIL (UNII: 9TLV70SV6I) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR Tocopherol (UNII: R0ZB2556P8) INGR Allantoin (UNII: 344S277G0Z) INGR Maltodextrin (UNII: 7CVR7L4A2D) INGR GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX) INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0) INGR CHAMOMILE (UNII: FGL3685T2X) INGR LAVENDER OIL (UNII: ZBP1YXW0H8) INGR Bromelains (UNII: U182GP2CF3) INGR Phenoxyethanol (UNII: HIE492ZZ3T) 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 05/01/2018 Part 6 of 6 ULTRA-LIGHT HYDRA
moisturizing gelProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR C12-15 Alkyl Ethylhexanoate (UNII: GQJ580CH83) INGR Pentylene Glycol (UNII: 50C1307PZG) INGR Glycerin (UNII: PDC6A3C0OX) INGR Betaine (UNII: 3SCV180C9W) INGR Dimethicone (UNII: 92RU3N3Y1O) INGR Saccharide Isomerate (UNII: W8K377W98I) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR Cetearyl Olivate (UNII: 58B69Q84JO) INGR CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) INGR Sorbitan Olivate (UNII: MDL271E3GR) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR Urea (UNII: 8W8T17847W) INGR LAVENDER OIL (UNII: ZBP1YXW0H8) INGR Caprylyl Glycol (UNII: 00YIU5438U) INGR Ethylhexylglycerin (UNII: 147D247K3P) INGR Sodium Hydroxide (UNII: 55X04QC32I) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR Trehalose (UNII: B8WCK70T7I) INGR Xanthan Gum (UNII: TTV12P4NEE) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR Butylene Glycol (UNII: 3XUS85K0RA) INGR Hexylene Glycol (UNII: KEH0A3F75J) INGR SAGE OIL (UNII: U27K0H1H2O) INGR Triacetin (UNII: XHX3C3X673) INGR GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) INGR Hyaluronic Acid (UNII: S270N0TRQY) INGR Silanetriol (UNII: E52D0J3TS5) INGR Sorbic Acid (UNII: X045WJ989B) INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0) INGR CENTELLA ASIATICA (UNII: 7M867G6T1U) INGR ORANGE (UNII: 5EVU04N5QU) INGR LEMON (UNII: 24RS0A988O) INGR BILBERRY (UNII: 9P2U39H18W) INGR VITIS VINIFERA SEED (UNII: C34U15ICXA) INGR EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 05/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2018 Labeler - Van Laere LLC (081010441)
