SEI BELLA TINTED BB MOISTURIZING CREAM- 410 n lotion

Sei Bella Tinted BB Moisturizing Cream by

Drug Labeling and Warnings

Sei Bella Tinted BB Moisturizing Cream 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%

Sunscreen

INDICATIONS & USAGE

■ helps prevent sunburn
■ if used as directed with other sun protection measures (see Directions), decreases 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 product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

■ apply smoothly on cleansed skin
■ 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 of age: ask a doctor
■ Sun Protection Measures.
Spending time in the sun increases your 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

CLINICAL STUDIES

■ for normal to oily skin
■ dermatologist tested
■ may stain some fabrics

■ protect this product from excessive heat and direct sun
■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

INACTIVE INGREDIENT

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, panax ginseng root extract, ginkgo biloba leaf extract, camellia sinensis leaf extract, chamomilla recutita (matricaria) flower 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, (+/-): iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891), mica

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEI BELLA TINTED BB MOISTURIZING CREAM 
410 n lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-408
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
OCTYLDODECANOL (UNII: 461N1O614Y)
BORON NITRIDE (UNII: 2U4T60A6YD)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
TOCOPHEROL (UNII: R0ZB2556P8)
LYSINE (UNII: K3Z4F929H6)
PALMITIC ACID (UNII: 2V16EO95H1)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
AQUA (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ZINC CHLORIDE (UNII: 86Q357L16B)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
METHICONE (20 CST) (UNII: 6777U11MKT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PHYTANTRIOL (UNII: 8LVI07A72W)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-408-01	30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2025

Labeler - Melaleuca Inc. (139760102)

Registrant - Melaleuca Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Mana		078870292	manufacture(54473-408)