Sei Bella Age-Defying Liquid Foundation - Beige

Sei Bella Age-Defying Liquid Foundation - Beige

Drug Labeling and Warnings

Drug Details

k">

SEI BELLA AGE-DEFYING LIQUID FOUNDATION BEIGE- octinoxate 7.5% 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.

----------

Sei Bella Age-Defying Liquid Foundation - Beige

Active Ingredient

Octinoxate 7.5%

Purpose

Sunscreen

Use

■ helps prevent sunburn

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

1,2-hexanediol, aminomethyl propanol, avena sativa (oat) kernel extract, butylene glycol, C20-22 alcohols, C20-22 alkyl phosphate, caprylic/capric triglyceride, caprylyl glycol, carnosine, cyclopentasiloxane, DI-PPG-3 myristyl ether adipate, disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate, hydrogenated palm glycerides, lecithin, iron oxides (CI77492, CI77491, CI77499), PEG/PPG-20/15 dimethicone, PEG-100 stearate, pentylene glycol, phenyl methicone, phenyl trimethicone, polyethylene, polymethylsilsesquioxane, polysorbate 80, potassium cetyl phosphate, salicornia herbacea extract, simethicone, tetrahexyldecyl ascorbate, tetrapeptide-21, titanium dioxide (CI77891), tocopheryl acetate, tremella fuciformis sporocarp extract, trimethylsiloxysilicate, water (aqua/eau), xanthan gum

Foundation Box

SEI BELLA AGE-DEFYING LIQUID FOUNDATION  BEIGE
octinoxate 7.5% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54473-228
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
C20-22 ALCOHOLS (UNII: O4M0347C6A)  
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARNOSINE (UNII: 8HO6PVN24W)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
OAT (UNII: Z6J799EAJK)  
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
SALICORNIA EUROPAEA (UNII: 6ADL50JAKW)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TETRAPEPTIDE-21 (UNII: 179JUC43HU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54473-228-011 in 1 BOX01/01/2018
130 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 finalpart35210/01/2012
Labeler - Melaleuca Inc. (139760102)
Registrant - Melaleuca Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca Inc.079711683manufacture(54473-228)

Revised: 3/2018
 
Melaleuca Inc.


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.