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

Sei Bella by

Drug Labeling and Warnings

Sei Bella by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose
Sunscreen

INDICATIONS & USAGE

Use

• provides moderate protection against sunburn
  

WARNINGS

Warnings
For external use only

WHEN USING

When using this product

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

STOP USE

Stop use and ask a doctor if

• rash or irritation develops and lasts
  

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• apply smoothly on cleansed skin before sun exposure and as needed
• children under 6 months of age: ask a doctor
  

CLINICAL STUDIES

Other information

• dermatologist and allergy tested
  

GENERAL PRECAUTIONS

• 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
  

STORAGE AND HANDLING

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

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

INGREDIENTS AND APPEARANCE

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

Product 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)