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

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

NYDG TRAVEL ESSENTIALS
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71994-009

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71994-009-01	1 in 1 CARTON	05/01/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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 cream

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	175 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	05/01/2018

Part 2 of 6

LUMINIZING SKIN ESSENCE
moisturizing gel

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		05/01/2018

Part 3 of 6

FORMULA 119
moisturizing cream

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		15 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		05/01/2018

Part 4 of 6

RE-CONTOUR EYE
eye lotion gel

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		05/01/2018

Part 5 of 6

COLLOIDAL OATMEAL CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		05/01/2018

Part 6 of 6

ULTRA-LIGHT HYDRA
moisturizing gel

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		05/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	05/01/2018

Labeler - Van Laere LLC (081010441)

NYDG Travel Essentials