SEI BELLA TINTED BB MOISTURIZING CREME BROADSPECTRUM SPF 20 TAN 440 C- avobenzone and octinoxate lotion

Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 by

Drug Labeling and Warnings

Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by Melaleuca Inc, Northwest Cosmetic Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3.0%

Octinoxate 7.5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• is 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

Keep Out of the Reach of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using

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

Do not use

Do not use on damaged or broken skin.

Directions

Directions

• apply smoothly on cleased 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 10a.m.-2p.m
• wear long-sleeve shirts, pants, hats, and sunglasses

Other Information

• may stain some fabrics
• protect this product from excessive heat and direct sun
• do not store at temperatures below 32oF (0oC) or above 120oF (49oC)

Other Information

dermatologist and allergy tested

Inactive ingredients

aqua (water/eau), isododecane, glycerin, acrylates crosspolymer, isoamyl laurate, octyldodecyl oleate, polyglyceryl-4 diisostearate/polyhydroxustearate/sebacate, titanium dioxide (CI 77891), polypropylene, cyclopentasiloxane, ethylhexyl palmitate, dimethicone, magnesium sulfate, glyceryl caprylate, microcrystalline wax, phenyl trimethicone, quaternium-90 bentonite, sodium chloride, hydrogenated castor oil, hydrolyzed jojoba esters, gluconolactone, mica (CI 77019), citrullur lanatus (watermelon), polysilicone-11, isoamyl cocoate, iron oxides (CI 77491, CI 77492, CI 77499), sodium benzoate, lens esculenta (lentil) fruit extract, propylene carbonate, glyceryl undecylenate, pyrus malus (apple) fruit extract, tetrahexyldecyl ascorbate, tocopheryl acetate, laminaria digitata extract, sodium lactate, hydroxypropyl cyclodextrin, sodium PCA, calcium gluconate, phenoxyethanol, potassium sorbate, tin oxide, palmitoyl tripeptide-38

Principal Display Panel

INGREDIENTS AND APPEARANCE

SEI BELLA TINTED BB MOISTURIZING CREME BROADSPECTRUM SPF 20  TAN 440 C
avobenzone and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-268
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.389 g  in 44.4 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.473 g  in 44.4 mL

Inactive Ingredients
Ingredient Name	Strength
LENTIL (UNII: 6O38V6B52O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM LACTATE (UNII: TU7HW0W0QT)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
1,1'-((1-METHYL-1,2-ETHANEDIYL)2-PROPENOIC ACID, BIS(OXY(1-METHYL-2,1-ETHANEDIYL))) ESTER (UNII: 2O70KL79K2)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MAGNESIUM SULFATE (UNII: DE08037SAB)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
STANNIC OXIDE (UNII: KM7N50LOS6)
CITRULLUS LANATUS VAR. LANATUS WHOLE (UNII: 3J5I6254YO)
GLYCERYL MONOUNDECYLENATE (UNII: IK8A76Q5G8)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
ISOLAN (UNII: K7716TIH63)
CYCLOMETHICONE (UNII: NMQ347994Z)
ISOAMYL COCOATE (UNII: 14OG46E98E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
APPLE FRUIT OIL (UNII: 9NT987I3A8)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-268-01	1 in 1 BOX	09/01/2016
1		44.4 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/01/2016

Labeler - Melaleuca Inc (139760102)

Registrant - Melaleuca Inc (079287544)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Labs		929572014	manufacture(54473-268)