THE GLOBAL TRAVEL KIT- zinc oxide kit

The Global Travel Kit by

Drug Labeling and Warnings

The Global Travel Kit by is a Otc medication manufactured, distributed, or labeled by Rationale Group Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 24%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.

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 Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours 
• Use a water resistant sunscreen if swimming or sweating.
• Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin ageing. 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.- 2p.m. Wear long sleeved shirts, pants, hats and sunglasses. 
• Children under 6 months of age: Ask a doctor.

Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Trisiloxane, Isoamyl Laurate, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cyclopentasiloxane, PEG-10 Dimethicone, Ethylhexyl Methoxycrylene, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Aqua (Water), Styrene/Acrylates Copolymer, Triacontanyl PVP, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Pentaerythrityl Tetraisostearate, Methyl Methacrylate Crosspolymer, Propanediol, Isostearic Acid, Glyceryl Caprylate, CI 77891 (Titanium Dioxide), Polyhydroxystearic Acid, Boron Nitride, 1,2-Hexanediol, Mica, Disteardimonium Hectorite, Glycerin, Sodium Chloride, CI 77492 (Iron Oxides), Bisabolol, Propylene Carbonate, Camellia Sinensis Leaf Extract, Hydrolyzed Keratin, Caprylhydroxamic Acid, Sodium Potassium Aluminum Silicate, Limonene, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Citrus Aurantium Dulcis (Orange) Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, 7-Dehydrocholesterol, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Maltodextrin, Silica, CI 77491 (Iron Oxides), Anigozanthos Flavidus Flower Extract, Syzygium Luehmannii Fruit Extract, Tin Oxide, Aspalathus Linearis Leaf Extract, Butylene Glycol, Sodium Lactate, Sodium PCA, Melanin, CI 77499 (Iron Oxides), Pentylene Glycol, Ceteareth-25, Linalool, Dimethicone, Magnesium Aspartate, Zinc Gluconate, Cetyl Alcohol, Citronellol, Sodium Hyaluronate, Davidsonia Pruriens Fruit Extract, Sodium Benzoate, Glycine, Ethylhexylglycerin, Potassium Sorbate, Behenic Acid, Ceramide NP, Cholesterol, Copper Gluconate, Fructose, Inositol, Lactic Acid, Niacinamide, Urea, Phenoxyethanol, Citric Acid, Ceramide NS, Serine, Glutamic Acid, Ceramide AP, Ceramide EOP, Ceramide EOS, Aspartic Acid, Leucine, Acetyl Tetrapeptide-22, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Proline, Threonine, Valine, Isoleucine, Histidine.

Package Labeling: Kit (

83108-110-00)

Package Labeling: Drug Kit Component (

83108-001-25)

Package Labeling: Non-Drug Kit Components

INGREDIENTS AND APPEARANCE

THE GLOBAL TRAVEL KIT 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83108-110

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83108-110-00	1 in 1 KIT	09/01/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	15 mL

Part 1 of 1

THE TINTED SERUM BROAD SPECTRUM SPF 50 
zinc oxide emulsion

Product Information
Item Code (Source)	NDC: 83108-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	240 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TRISILOXANE (UNII: 9G1ZW13R0G)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
WATER (UNII: 059QF0KO0R)
STYRENE (UNII: 44LJ2U959V)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
PROPANEDIOL (UNII: 5965N8W85T)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BORON NITRIDE (UNII: 2U4T60A6YD)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MICA (UNII: V8A1AW0880)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LEVOMENOL (UNII: 24WE03BX2T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SODIUM POTASSIUM ALUMINUM SILICATE (UNII: Z6C6FF3Y9R)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRUS BERGAMIA LEAF OIL (UNII: ZVY8741I1V)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)
CLOVE LEAF OIL (UNII: VCA5491KVF)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANIGOZANTHOS FLAVIDUS FLOWERING TOP (UNII: RP2O43NDZC)
SYZYGIUM LUEHMANNII FRUIT (UNII: 47QSB3L4KG)
STANNIC OXIDE (UNII: KM7N50LOS6)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETEARETH-25 (UNII: 8FA93U5T67)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
CETYL ALCOHOL (UNII: 936JST6JCN)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DAVIDSONIA PRURIENS FRUIT (UNII: Q0AJF937HY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCINE (UNII: TE7660XO1C)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BEHENIC ACID (UNII: H390488X0A)
CERAMIDE NP (UNII: 4370DF050B)
CHOLESTEROL (UNII: 97C5T2UQ7J)
COPPER GLUCONATE (UNII: RV823G6G67)
FRUCTOSE (UNII: 6YSS42VSEV)
INOSITOL (UNII: 4L6452S749)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
NIACINAMIDE (UNII: 25X51I8RD4)
UREA (UNII: 8W8T17847W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CERAMIDE NS (UNII: V7M2259XJM)
SERINE (UNII: 452VLY9402)
GLUTAMIC ACID (UNII: 3KX376GY7L)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE EOS (UNII: CR0J8RN66K)
ASPARTIC ACID (UNII: 30KYC7MIAI)
LEUCINE (UNII: GMW67QNF9C)
CAPROOYL PHYTOSPHINGOSINE (UNII: 2FD4Y5XL2L)
N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)
ALANINE (UNII: OF5P57N2ZX)
LYSINE (UNII: K3Z4F929H6)
ARGININE (UNII: 94ZLA3W45F)
TYROSINE (UNII: 42HK56048U)
PHENYLALANINE (UNII: 47E5O17Y3R)
PROLINE (UNII: 9DLQ4CIU6V)
THREONINE (UNII: 2ZD004190S)
VALINE (UNII: HG18B9YRS7)
ISOLEUCINE (UNII: 04Y7590D77)
HISTIDINE (UNII: 4QD397987E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83108-001-25	1 in 1 CARTON
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
OTC Monograph Drug	M020	09/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2024

Labeler - Rationale Group Pty Ltd (756927393)