Sei Bella Advanced Revital R3 Age-Defying Creme - SPF 25 - Normal to Dry

Sei Bella Advanced Revital R3 Age-Defying Creme - SPF 25 - Normal to Dry

Drug Labeling and Warnings

Drug Details

k">

SEI BELLA ADVANCED REVITAL R3 AGE DEFYING CREME- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream 
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.

----------

Sei Bella Advanced Revital R3 Age-Defying Creme - SPF 25 - Normal to Dry

Active ingredients
Avobenzone 1.8%, Homosalate 6%, Octisalate 3%, Octocrylane 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 6 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, 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

Age Defying Triple Benefit Creme

SEI BELLA  ADVANCED REVITAL R3 AGE DEFYING CREME
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54473-276
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
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)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
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)  
ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)  
SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)  
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
BROCCOLI SPROUT (UNII: 128UH9LOAE)  
OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54473-276-011 in 1 BOX01/01/2018
1NDC: 54473-276-5050 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2018
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.079711683manufacture(54473-276)

Revised: 2/2018
 
Melaleuca, Inc.


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.