Label: LUMINOSITY ACTIVATION DAY EDITION- zinc oxide kit
- NDC Code(s): 83108-001-13, 83108-100-00
- Packager: Rationale Group Pty Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 18, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Uses
- Warnings
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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
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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, Pentaerhthrityl 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, Asparic Acid, Leucine, Acetyl Tetrapeptide-22, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Propine, Threonine, Valine, Isoleucine, Histidine
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LUMINOSITY ACTIVATION DAY EDITION
zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83108-100 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83108-100-00 1 in 1 KIT 11/15/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 3 mL Part 1 of 1 THE TINTED SERUM BROAD SPECTRUM SPF 50
zinc oxide emulsionProduct 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) LYSINE (UNII: K3Z4F929H6) 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) 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) FERRIC OXIDE RED (UNII: 1K09F3G675) 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 (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 (UNII: 33X04XA5AT) NIACINAMIDE (UNII: 25X51I8RD4) UREA (UNII: 8W8T17847W) PHENOXYETHANOL (UNII: HIE492ZZ3T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CERAMIDE NG (UNII: C04977SRJ5) SERINE (UNII: 452VLY9402) GLUTAMIC ACID (UNII: 3KX376GY7L) CERAMIDE AP (UNII: F1X8L2B00J) 3-DEHYDROXY CERAMIDE 1 (UNII: CR0J8RN66K) ASPARTIC ACID (UNII: 30KYC7MIAI) LEUCINE (UNII: GMW67QNF9C) CAPROOYL PHYTOSPHINGOSINE (UNII: 2FD4Y5XL2L) N-HEXANOYLSPHINGOSINE (UNII: 038753E78J) ALANINE (UNII: OF5P57N2ZX) ARGININE (UNII: 94ZLA3W45F) TYROSINE (UNII: 42HK56048U) PHENYLALANINE (UNII: 47E5O17Y3R) DIPIVEFRIN HYDROCHLORIDE (UNII: 5QTH9UHV0K) 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:83108-001-13 3 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 11/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/15/2023 Labeler - Rationale Group Pty Ltd (756927393)