SEI BELLA FLAWLESS LIQUID FOUNDATION 490 N- octinoxate 6% octisalate 5% titanium dioxide 2% lotion

Sei Bella Flawless Liquid Foundation by

Drug Labeling and Warnings

Sei Bella Flawless Liquid Foundation by is a Otc medication manufactured, distributed, or labeled by Melaleuca Inc., Process Technologies & Packaging LLC.. 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

isododecane, water, titanium oxide, dodecane, ethylhexyl palmitate, propanediol, polymethylsilsesquioxane, trimethylsiloxysilicate, peg-10 dimethicone, polysilicone-11, peg/ppg-18/18 dimethicone, dimethicone, barium sulfate, lecithin, glycerin, disteardimonium hectorite, magnesium aluminum silicate, phenoxyethanol, polysorbate 20, c18-36 acid triglyceride, caprylyl glycol, propylene carbonate, triethoxycaprylylsilane, calcium silicate, xanthum gum, cellulose gum, ouptnia ficus-indica stem extract, quartz, palmitoyl hexapeptide-19, may contain: iron oxide CI 77492, iron oxide 77491, iron oxide 77499

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEI BELLA FLAWLESS LIQUID FOUNDATION  490 N
octinoxate 6% octisalate 5% titanium dioxide 2% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-320
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.5 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.8 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.6 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
CALCIUM SILICATE (UNII: S4255P4G5M)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DODECANE (UNII: 11A386X1QH)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPANEDIOL (UNII: 5965N8W85T)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYSILICONE-15 (UNII: F8DRP5BB29)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-320-01	1 in 1 BOX	06/01/2020
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	06/01/2020

Labeler - Melaleuca Inc. (139760102)

Registrant - Melaleuca Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Process Technologies & Packaging LLC.		809172885	manufacture(54473-320)