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

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

Drug Labeling and Warnings

Drug Details

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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

  • provides moderate protection against sunburn

Warnings
For external use only

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • rash or irritation develops and lasts

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

Directions

  • apply smoothly on cleansed skin before sun exposure and as needed
  • children under six months of age: ask a doctor

Other information

  • dermatologist and allergy tested

  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
  • may stain some fabrics

  • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

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)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)  
UBIDECARENONE (UNII: EJ27X76M46)  
LEVOMENOL (UNII: 24WE03BX2T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
TETRAPEPTIDE-21 (UNII: 179JUC43HU)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
MONTMORILLONITE (UNII: A585MN1H2L)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
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: 2/2018
 
Melaleuca, Inc.


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