SEI BELLA TINTED BB MOISTURIZING CREME BROADSPECTRUM SPF 20 BEIGE 320 W- avobenzone and octinoxate 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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Tinted BB Moisturizing Creme Broad-Spectrum SPF 20 Sunscreen

Active Ingredients

Avobenzone 3.0%

Octinoxate 7.5%

Purpose

Sunscreen

Uses

Warnings

For External Use Only

Keep Out of the Reach of Children

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

When using

When using this product keep out of eyes. Rinse with water to remove.

Do not use

Do not use on damaged or broken skin.

Directions

Directions

Other Information

Other Information

dermatologist and allergy tested

Inactive ingredients

aqua (water/eau), isododecane, glycerin, acrylates crosspolymer, isoamyl laurate, octyldodecyl oleate, polyglyceryl-4 diisostearate/polyhydroxustearate/sebacate, titanium dioxide (CI 77891), polypropylene, cyclopentasiloxane, ethylhexyl palmitate, dimethicone, magnesium sulfate, glyceryl caprylate, microcrystalline wax, phenyl trimethicone, quaternium-90 bentonite, sodium chloride, hydrogenated castor oil, hydrolyzed jojoba esters, gluconolactone, mica (CI 77019), citrullur lanatus (watermelon), polysilicone-11, isoamyl cocoate, iron oxides (CI 77491, CI 77492, CI 77499), sodium benzoate, lens esculenta (lentil) fruit extract, propylene carbonate, glyceryl undecylenate, pyrus malus (apple) fruit extract, tetrahexyldecyl ascorbate, tocopheryl acetate, laminaria digitata extract, sodium lactate, hydroxypropyl cyclodextrin, sodium PCA, calcium gluconate, phenoxyethanol, potassium sorbate, tin oxide, palmitoyl tripeptide-38

Principal Display Panel

Tinted BB Moistrizing Creme Box

SEI BELLA TINTED BB MOISTURIZING CREME BROADSPECTRUM SPF 20  BEIGE 320 W
avobenzone and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-266
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.389 g  in 44.4 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.473 g  in 44.4 mL
Inactive Ingredients
Ingredient NameStrength
LENTIL (UNII: 6O38V6B52O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
1,1'-((1-METHYL-1,2-ETHANEDIYL)2-PROPENOIC ACID, BIS(OXY(1-METHYL-2,1-ETHANEDIYL))) ESTER (UNII: 2O70KL79K2)  
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
CITRULLUS LANATUS VAR. LANATUS WHOLE (UNII: 3J5I6254YO)  
GLYCERYL MONOUNDECYLENATE (UNII: IK8A76Q5G8)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
ISOLAN (UNII: K7716TIH63)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
ISOAMYL COCOATE (UNII: 14OG46E98E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
APPLE FRUIT OIL (UNII: 9NT987I3A8)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-266-011 in 1 BOX09/01/2016
144.4 mL in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/01/2016
Labeler - Melaleuca Inc (139760102)
Registrant - Melaleuca Inc (079287544)
Establishment
NameAddressID/FEIBusiness Operations
Northwest Cosmetic Labs929572014manufacture(54473-266)

Revised: 5/2016
Document Id: 3233082a-3e2d-7248-e054-00144ff8d46c
Set id: 303b37f1-2759-6379-e054-00144ff8d46c
Version: 2
Effective Time: 20160506
 
Melaleuca Inc