SEI BELLA AGE-DEFYING LIQUID FOUNDATION ESPRESSO- octinoxate 7.5% lotion

Sei Bella Age-Defying Liquid Foundation by

Drug Labeling and Warnings

Sei Bella Age-Defying Liquid Foundation by is a Otc medication manufactured, distributed, or labeled by Melaleuca Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

STOP USE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEI BELLA AGE-DEFYING LIQUID FOUNDATION  ESPRESSO
octinoxate 7.5% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.25 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
.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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-232-01	1 in 1 BOX	01/01/2018
1		30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2012

Labeler - Melaleuca Inc. (139760102)

Registrant - Melaleuca Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca Inc.		079711683	manufacture(54473-232)