Sei Bella CC Brightening Creme - Medium Tan

Sei Bella CC Brightening Creme - Medium Tan

Drug Labeling and Warnings

Drug Details

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SEI BELLA CC BRIGHTENING CREME MEDIUM TAN- octinoxate 7.5%, titanium dioxide 5%, zinc oxide 1% 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 CC Brightening Creme - Medium Tan

Active Ingredient

Octinoxate 7.5%

Titanium Dioxide 5%

Zinc Oxide 1%

Purpose

Sunscreen

Use

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), descreases the risk of skin cancer and early skin aging caused by the sun.

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

■ apply after cleanser, toner, and foundation primer. Blend outward with Sei Bella foundation brush or fingers.

■ apply liberally 15 minutes before sun exposure

■ use a water-resistant sunscreen if swimming or sweating

■ reapply at least every 2 hours

■ children under 6 months: ask a doctor

Sun Protection Measures. Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF value of 15 or higher and other sun protection measures including:

■ limit time in the sun, especially from 10 a.m.-2 p.m.

■ wear long-sleeve shirts, pants, hats, and sunglasses

Other information

■ dermatologist and allergy tested

■ protect this product from excesssive heat and direct sun

Inactive ingredients

Aqua/Water/Eau, Dimethicone, Glycerin, PEG/PPG-18/18 Dimethicone, Butylene Glycol, Trimethylsiloxysilicate, Saccharide Isomerate, Tocopherol, Ascorbyl Palmitate, Rose Extract, Caprylic/Capric Triglyceride, Octyldodecyl Neopentanoate , Ethylhexyl Palmitate, Nylon-12, Boron Nitride, Dextrin Palmitate, Sodium Chloride, Aluminum Hydroxide, Polymethylsilsesquioxane, Glyceryl Polyacrylate, HDI/Trimethylol Hexyllactone Crosspolymer, Dimethylmethoxy Chromanyl Palmitate, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane, Calcium Silicate, Palmitic Acid, Stearic Acid, Citric Acid , Lecithin, Acrylates/Ammonium Methacrylate Copolymer, Sodium Citrate, Triethyl Citrate , Acrylates Crosspolymer, Disteardimonium Hectorite, Xanthan Gum, Alcohol, Alcohol Denat., Methicone, Triethoxycaprylylsilane, Lysine, Potassium Chloride, Magnesium Chloride, Zinc Chloride, Sodium Hyaluronate, Sodium Dehydroacetate, Magnesium Ascorbyl Phosphate, Octyldodecanol, Potassium Sorbate, Disodium EDTA, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol


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

Brightening CC Cream

SEI BELLA CC BRIGHTENING CREME  MEDIUM TAN
octinoxate 7.5%, titanium dioxide 5%, zinc oxide 1% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54473-282
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.65 g  in 33 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.475 g  in 33 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.3267 g  in 33 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ROSA ALBA FLOWER OIL (UNII: FF1Y064QVO)  
NYLON-12 (UNII: 446U8J075B)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
AMMONIUM METHACRYLATE (UNII: J2243103QO)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
XANTHAN GUM (UNII: TTV12P4NEE)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN)  
PALMITIC ACID (UNII: 2V16EO95H1)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ALCOHOL (UNII: 3K9958V90M)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BENZIMIDAZOLE (UNII: E24GX49LD8)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54473-282-011 in 1 BOX01/01/2018
1NDC: 54473-282-3033 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 finalpart35205/01/2017
Labeler - Melaleuca Inc. (139760102)
Registrant - Melaleuca Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Mana078870292manufacture(54473-282)

Revised: 3/2018
 
Melaleuca Inc.


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