SEI BELLA SKIN REFINING TINTED MOISTURIZER CLASSIC BEIGE- titanium dioxide 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 Skin-Refining Tinted Moisturizer - Broadspectrum SPF 20 - Classic Beige

Active Ingredients

Titanium Dioxide 6.5%

Purpose

Sunscreen

Uses

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

Directions

Other Information

for normal-to-oily skin

dermatologist and allergy tested

  • may stain some fabrics
  • protect this product from excessive heat and direct sun
  • do not store at temperatures below 32oF (0oC) or above 120oF (49oC)

Inactive Ingredients

1,2-hexandiol, aloe barbadensis leaf juice, alumina, aminomethyl propanol, aqua (water/eau), beta-glucan, butylene glycol, butyrospermum parkii (shea butter), caprylic/capric tryglyceride, caprylyl glycol, carnosine, cetearyl alcohol, ceteth-10 phosphate, cetyl palmitate, cucumis sativus (cucumber) fruit extract, cyclopentasilloxane, dicetyl phosphate, disodium EDTA, ethylhexylglycerin, glycerin, glycine soja (soybean) oil, hydrogenated cottonseed oil, hydrogenated palm glycerides, iron oxides (CI77491, CI77492, CI77499), isostearic acid, lecithin, octyldodecyl neopentanoate, PEG/PPG-20/15 dimethicone, pentylene glycol, phenyl methicone, polyethylene, polyglyceryl-3, polyricinoleate, polyhydroxystearic acid, polymethylsilsesquioxane, polysorbate 60, polysorbate 80, potassium cetyl phosphate, propylheptyl caprylate, simethicone, stearic acid, tetrahexyldecyl ascorbate, tetrapeptide-21, titanium dioxide (CI77891), tocopheryl acetate, tremella fuciformis sporocarp extract, vitis vinifera (grape) leaf extract, xanthan gum

Tint Moist Box

SEI BELLA SKIN REFINING TINTED MOISTURIZER  CLASSIC BEIGE
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-248
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.866 g  in 44.4 mL
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARNOSINE (UNII: 8HO6PVN24W)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
CUCUMBER (UNII: YY7C30VXJT)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
glycerin (UNII: PDC6A3C0OX)  
SOYBEAN OIL (UNII: 241ATL177A)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TETRAPEPTIDE-21 (UNII: 179JUC43HU)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
VITIS VINIFERA LEAF (UNII: R1H893D80E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-248-011 in 1 BOX
144.4 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2013
Labeler - Melaleuca Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca Inc.079287544manufacture(54473-248)

Revised: 4/2014
Document Id: e99547a1-a44b-45e5-ada9-90321c09d4d8
Set id: a332d270-d57c-42bb-8c85-f259727cfc2e
Version: 1
Effective Time: 20140428
 
Melaleuca Inc.