Label: SEI BELLA ADVANCED REVITAL R3 AGE DEFYING CREME- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54473-276-01, 54473-276-50 - Packager: Melaleuca, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 March 19, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- CLINICAL STUDIES
- GENERAL PRECAUTIONS
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
aqua (water/eau), polyacrylate-15, polyacrylate-17, glycerin, cetyl palmitate, C20-22 alkyl phosphate, C20-22 alcohols, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, trisloxane, dimethicone, cyclopentasiloxane, dimethicone crosspolymer, C14-22 alcohols, C12-20 alkyl glucoside, propylheptyl caprylate, caprylic/capric triglycerides, acetyl tetrapeptide-9, phenoxyethanol, cetyl alcohol, xanthan gum, triethanolamine, sodium polyacrylate, potassium sorbate, trisodium ethylenediamine disuccinate, parfum, bisabolol, panax ginseng root extract, camellia oleifera leaf extract, lycium barbarum fruit extract, aloe barbadensis leaf juice, ginkgo biloba leaf extract, butylene glycol, allantoin, tocopheryl acetate, linalool, hexyl cinnamal, benzyl salicylate, alpha isomethyl ionone
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SEI BELLA ADVANCED REVITAL R3 AGE DEFYING CREME
avobenzone, homosalate, octisalate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-276 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.9 g in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.93 g in 50 mL Inactive Ingredients Ingredient Name Strength SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PROPANEDIOL (UNII: 5965N8W85T) TETRAPEPTIDE-21 (UNII: 179JUC43HU) POLYSACCHARIDE-K (UNII: 3X48A86C8K) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) MALTODEXTRIN (UNII: 7CVR7L4A2D) TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) UBIDECARENONE (UNII: EJ27X76M46) ASIAN GINSENG (UNII: CUQ3A77YXI) ZINC PIDOLATE (UNII: C32PQ86DH4) NIACINAMIDE (UNII: 25X51I8RD4) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) TREHALOSE (UNII: B8WCK70T7I) DIMETHICONE (UNII: 92RU3N3Y1O) POLYSORBATE 60 (UNII: CAL22UVI4M) GLYCERIN (UNII: PDC6A3C0OX) AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) SQUALANE (UNII: GW89575KF9) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) SHEA BUTTER (UNII: K49155WL9Y) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ALLANTOIN (UNII: 344S277G0Z) CARNOSINE (UNII: 8HO6PVN24W) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) WATER (UNII: 059QF0KO0R) HYALURONIC ACID (UNII: S270N0TRQY) OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L) ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889) SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U) CITRUS BIOFLAVONOIDS (UNII: BD70459I50) BROCCOLI SPROUT (UNII: 128UH9LOAE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-276-01 1 in 1 BOX 01/01/2018 1 NDC:54473-276-50 50 mL in 1 JAR; 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 01/01/2018 Labeler - Melaleuca, Inc. (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc. 079711683 manufacture(54473-276)