Label: THE ENRICHED EYE CREME BROAD SPECTRUM SPF15- zinc oxide emulsion
- NDC Code(s): 83108-002-00, 83108-002-02
- Packager: Rationale Group Pty Ltd
- Category: HUMAN OTC DRUG LABEL
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 December 17, 2022
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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
Aqua (Water), Dimethicone, Glycerin, Pentylene Glycol, PEG-10 Dimethicone, Tribehenin PEG-20 Esters, Ethylhexyl Methoxycrylene, Coco-Caprylate, Polyhydroxystearic Acid, Propanediol, Argania Spinosa Kernel Oil, Dimethicone Crosspolymer, Polyurethane-62, Tocopheryl Acetate, CI 77891 (Titanium Dioxide), Polyacrylamide, 1,2-Hexanediol, Silica, C13-14 Isoparaffin, Maltodextrin, Mica, Sodium Potassium Aluminum Silicate, Tocopherol, Butylene Glycol, Limonene, Tocotrienols, Laureth-7, Caprylhydroxamic Acid, Disodium EDTA, Hydrolyzed Keratin, Santalum Spicatum (Sandalwood) Seed Oil, Trideceth-10, Voandzeia Subterranea Seed Extract, Behenyl Alcohol, Bisabolol, Polyglyceryl-10 Pentastearate, Helianthus Annuus (Sunflower) Seed Oil, Citrus Aurantium Dulcis (Orange) Oil, Anigozanthos Flavidus Flower Extract, Davidsonia Jerseyana Fruit Extract, Syzygium Luehmannii Fruit Extract, Tin Oxide, Citric Acid, Ceteareth-25, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Fructose, Litsea Cubeba Fruit Oil, Sodium Hydroxide, Urea, Citral, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Sodium Stearoyl Lactylate, CI 77491 (Iron Oxides), Ceramide NP, 7-Dehydrocholesterol, Cetyl Alcohol, Elaeis Guineensis (Palm) Oil, Melanin, Allantoin, Maltose, Sodium Chloride, Sodium Lactate, Sodium PCA, Trehalose, Magnesium Aspartate, Zinc Gluconate, Linalool, Behenic Acid, Ceramide AP, Cholesterol, Ceramide NG, Phytosphingosine, Ceramide NS, Sodium Hyaluronate, Glycine, Acetyl Tetrapeptide-22, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Serine, Glutamic Acid, Ceramide EOP, Ceramide EOS, Copper Gluconate, Glucose, Aspartic Acid, Leucine, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Alanine, Lysine, Ethylhexylglycerin, Arginine, Tyrosine, Phenylalanine, Proline, Threonine, Valine, Isoleucine, Histidine.
- Package Labeling:20ml
- Package Labeling:2ml
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INGREDIENTS AND APPEARANCE
THE ENRICHED EYE CREME BROAD SPECTRUM SPF15
zinc oxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83108-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 120 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PENTYLENE GLYCOL (UNII: 50C1307PZG) TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) COCO-CAPRYLATE (UNII: 4828G836N6) PROPANEDIOL (UNII: 5965N8W85T) ARGAN OIL (UNII: 4V59G5UW9X) POLYURETHANE-62 (UNII: TBK645J3J8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICA (UNII: V8A1AW0880) TOCOPHEROL (UNII: R0ZB2556P8) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) LIMONENE, (+)- (UNII: GFD7C86Q1W) TOCOTRIENOLS (UNII: KP2MW85SSQ) LAURETH-7 (UNII: Z95S6G8201) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SANDALWOOD (UNII: 3641YW25N2) TRIDECETH-10 (UNII: G624N6MSBA) BAMBARA GROUNDNUT (UNII: 4T235SD5XE) DOCOSANOL (UNII: 9G1OE216XY) LEVOMENOL (UNII: 24WE03BX2T) POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701) SUNFLOWER OIL (UNII: 3W1JG795YI) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) ANIGOZANTHOS FLAVIDUS FLOWERING TOP (UNII: RP2O43NDZC) SYZYGIUM LUEHMANNII FRUIT (UNII: 47QSB3L4KG) STANNIC OXIDE (UNII: KM7N50LOS6) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CETEARETH-25 (UNII: 8FA93U5T67) BERGAMOT OIL (UNII: 39W1PKE3JI) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) LEMON OIL, COLD PRESSED (UNII: I9GRO824LL) FRUCTOSE (UNII: 6YSS42VSEV) LITSEA OIL (UNII: 2XIW34BN6O) SODIUM HYDROXIDE (UNII: 55X04QC32I) UREA (UNII: 8W8T17847W) CITRAL (UNII: T7EU0O9VPP) CITRUS BERGAMIA LEAF OIL (UNII: ZVY8741I1V) JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686) GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH) CLOVE LEAF OIL (UNII: VCA5491KVF) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) FERRIC OXIDE RED (UNII: 1K09F3G675) CERAMIDE NP (UNII: 4370DF050B) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) CETYL ALCOHOL (UNII: 936JST6JCN) PALM OIL (UNII: 5QUO05548Z) ALLANTOIN (UNII: 344S277G0Z) MALTOSE (UNII: XJ6S9RV06F) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LACTATE (UNII: TU7HW0W0QT) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) TREHALOSE (UNII: B8WCK70T7I) MAGNESIUM ASPARTATE (UNII: R17X820ROL) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) LINALOOL, (+/-)- (UNII: D81QY6I88E) BEHENIC ACID (UNII: H390488X0A) CERAMIDE AP (UNII: F1X8L2B00J) CHOLESTEROL (UNII: 97C5T2UQ7J) CERAMIDE NG (UNII: C04977SRJ5) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GLYCINE (UNII: TE7660XO1C) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SERINE (UNII: 452VLY9402) GLUTAMIC ACID (UNII: 3KX376GY7L) 3-DEHYDROXY CERAMIDE 1 (UNII: CR0J8RN66K) COPPER GLUCONATE (UNII: RV823G6G67) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) ASPARTIC ACID (UNII: 30KYC7MIAI) LEUCINE (UNII: GMW67QNF9C) CAPROOYL PHYTOSPHINGOSINE (UNII: 2FD4Y5XL2L) N-HEXANOYLSPHINGOSINE (UNII: 038753E78J) ALANINE (UNII: OF5P57N2ZX) LYSINE (UNII: K3Z4F929H6) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 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:83108-002-00 1 in 1 BOX 12/08/2022 1 20 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:83108-002-02 2 mL in 1 JAR; Type 0: Not a Combination Product 12/08/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/08/2022 Labeler - Rationale Group Pty Ltd (756927393)