Label: 21STAY A THERA SUN BLOCK- octinoxate, zinc oxide, titanium dioxide, octisalate, homosalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71883-001-01, 71883-001-02 - Packager: Oracle Cosmetic Co., 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 November 21, 2017
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Cyclopentasiloxane, Glycerin, PEG-10 Dimethicone, Dicaprylyl Ether, Polymethyl Methacrylate, Dimethicone, Silica, Disteardimonium Hectorite, Sodium Chloride, Aluminum Hydroxide, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Bis-Ethylhexyloxyphenol, Polymethylsilsesquioxane, Stearic Acid, Fragrance, Phenoxyethanol, Dimethicone/Vinyl DimethiconeCrosspolymer, Sorbitan Sesquioleate, Dimethicone/Methicone Copolymer, Propanediol, Ethylhexylglycerin, Butylene Glycol, Octyldodecanol, Bambusa Vulgaris Extract, Echium Plantagineum Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cardiospermum HalicacabumFlower/Leaf/Vine Extract, Lepidium Meyenii Root Extract, Vitis Vinifera (Grape) Seed Oil, Tocopherol, Vegetable Oil, Camellia Sinensis Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Maltodextrin
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INGREDIENTS AND APPEARANCE
21STAY A THERA SUN BLOCK
octinoxate, zinc oxide, titanium dioxide, octisalate, homosalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71883-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 60 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 58.2 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 54.6 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) Dicaprylyl Ether (UNII: 77JZM5516Z) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CHIA SEED (UNII: NU0OLX06F8) CENTELLA ASIATICA (UNII: 7M867G6T1U) HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22) 1,2-Hexanediol (UNII: TR046Y3K1G) BEMOTRIZINOL (UNII: PWZ1720CBH) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) Stearic Acid (UNII: 4ELV7Z65AP) Phenoxyethanol (UNII: HIE492ZZ3T) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) Sorbitan Sesquioleate (UNII: 0W8RRI5W5A) PROPANEDIOL (UNII: 5965N8W85T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Butylene Glycol (UNII: 3XUS85K0RA) Octyldodecanol (UNII: 461N1O614Y) BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V) ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW) SUNFLOWER OIL (UNII: 3W1JG795YI) CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) LEPIDIUM MEYENII ROOT (UNII: HP7119212T) GRAPE SEED OIL (UNII: 930MLC8XGG) Tocopherol (UNII: R0ZB2556P8) CORN OIL (UNII: 8470G57WFM) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SAGE (UNII: 065C5D077J) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) Maltodextrin (UNII: 7CVR7L4A2D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71883-001-02 1 in 1 CARTON 11/21/2017 1 NDC:71883-001-01 40 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/21/2017 Labeler - Oracle Cosmetic Co., Ltd. (688258270) Registrant - Oracle Cosmetic Co., Ltd. (688258270) Establishment Name Address ID/FEI Business Operations COSON Co., Ltd._Osan Plant 689847210 manufacture(71883-001)
