SEI BELLA TINTED BB MOISTURIZING CREME MEDIUM 440 N- titanium dioxide 5% and zinc oxide 5% lotion

Sei Bella Tinted BB Moisturizing Creme by

Drug Labeling and Warnings

Sei Bella Tinted BB Moisturizing Creme by is a Otc medication manufactured, distributed, or labeled by Melaleuca Inc., Mana. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Titanium Dioxide 5%

Zinc Oxide 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

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Lysine, Tocopherol, Tetrahexyldecyl Ascorbate, Magnesium Ascorbyl Phosphate, Retinyl Palmitate, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Octyldodecanol, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Methicone, Stearic Acid, Aluminum Hydroxide, Hexylene Glycol, Disodium EDTA, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEI BELLA TINTED BB MOISTURIZING CREME  MEDIUM 440 N
titanium dioxide 5% and zinc oxide 5% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-287
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.5 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.5 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
OCTYLDODECANOL (UNII: 461N1O614Y)
BORON NITRIDE (UNII: 2U4T60A6YD)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
STEARIC ACID (UNII: 4ELV7Z65AP)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CHLORIDE (UNII: 86Q357L16B)
LYSINE (UNII: K3Z4F929H6)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
DIMETHICONE (UNII: 92RU3N3Y1O)
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
PHYTANTRIOL (UNII: 8LVI07A72W)
PALMITIC ACID (UNII: 2V16EO95H1)
METHICONE (20 CST) (UNII: 6777U11MKT)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
WATER (UNII: 059QF0KO0R)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-287-01	1 in 1 BOX	05/01/2018
1	NDC: 54473-287-30	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	05/01/2018

Labeler - Melaleuca Inc. (139760102)

Registrant - Melaleuca Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Mana		078870292	manufacture(54473-287)