ADVANCED REVITAL- avobenzone, homosalate, octocrylene lotion 
Melaleuca, Inc.

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.

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Sei Bella Advanced Revital R3 Age Defying Lotion SPF 25 Normal to Oily

Active ingredients
Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylene 1.86%, Oxybenzone 1.8%

Purpose
Sunscreen

Use

Warnings
For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients
aqua (water/eau), polyacrylate-15, polyacrylate-17, C20-22 alkyl phosphate, C20-22 alcohols, trisiloxane, dimethicone, cyclopentasiloxane, dimethicone crosspolymer, cetyl palmitate, glycerin, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, dicaprylyl carbonate, C14-22 alcohols, C12-20 alkyl glucoside, propylheptyl caprylate, acetyl tetrapeptide-9, phenoxyethanol, cetyl alcohol, caprylyl glycol, 1,2 hexanediol, triethanolamine, xanthan gum, trisodium ethylenediamine disuccinate, parfum, bisabolol, panax ginseng root extract, lycium barbarum fruit extract, aloe barbadensis leaf juice, camellia oleifera leaf extract, butylene glycol, allantoin, tocopheryl acetate, limonene, butylphenyl methylpropional

Age Defying Triple Benefit Lotion

ADVANCED REVITAL 
avobenzone, homosalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-277
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.9 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.93 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARNOSINE (UNII: 8HO6PVN24W)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
UBIDECARENONE (UNII: EJ27X76M46)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LEVOMENOL (UNII: 24WE03BX2T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
TETRAPEPTIDE-21 (UNII: 179JUC43HU)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
C12-16 ALCOHOLS (UNII: S4827SZE3L)  
PALMITIC ACID (UNII: 2V16EO95H1)  
TREHALOSE (UNII: B8WCK70T7I)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
SQUALANE (UNII: GW89575KF9)  
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PROPANEDIOL (UNII: 5965N8W85T)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
MONTMORILLONITE (UNII: A585MN1H2L)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
BROCCOLI SPROUT (UNII: 128UH9LOAE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-277-011 in 1 BOX01/01/2018
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2017
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.079711683manufacture(54473-277)

Revised: 3/2020
Document Id: a13d03b6-44e4-3865-e053-2995a90a584a
Set id: effc47e5-67fe-4e61-8eeb-4f77d8b8dab1
Version: 4
Effective Time: 20200319
 
Melaleuca, Inc.