SEI BELLA TINTED BB MOISTURIZING CREME DEEP 550 N- titanium dioxide 5% and zinc oxide 5% 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 Tinted BB Moisturizing Creme Deep 550 N

Active Ingredient

Titanium Dioxide 5%

Zinc Oxide 5%

Purpose

Sunscreen

Use

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

  • dermatologist and allergy tested

  • protect this product from excesssive heat and direct sun

Inactive ingredients

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Lysine, Tocopherol, Tetrahexyldecyl Ascorbate, Magnesium Ascorbyl Phosphate, Retinyl Palmitate, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Octyldodecanol, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Methicone, Stearic Acid, Aluminum Hydroxide, Hexylene Glycol, Disodium EDTA, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol

May Contain (+/-): Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Tinted BB Moisturizing Creme

SEI BELLA TINTED BB MOISTURIZING CREME  DEEP 550 N
titanium dioxide 5% and zinc oxide 5% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-290
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.5 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.5 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
LYSINE (UNII: K3Z4F929H6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
PALMITIC ACID (UNII: 2V16EO95H1)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
WATER (UNII: 059QF0KO0R)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-290-011 in 1 BOX05/01/2018
1NDC:54473-290-3030 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2018
Labeler - Melaleuca Inc. (139760102)
Registrant - Melaleuca Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Mana078870292manufacture(54473-290)

Revised: 5/2018
Document Id: 68e31a82-0cd1-5a1a-e053-2991aa0a33f8
Set id: 68e31a82-0cd0-5a1a-e053-2991aa0a33f8
Version: 1
Effective Time: 20180501
 
Melaleuca Inc.