Label: SEI BELLA TINTED BB MOISTURIZING CREME DEEP 550 N- titanium dioxide 5% and zinc oxide 5% lotion
- NDC Code(s): 54473-290-01, 54473-290-30
- Packager: Melaleuca Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 1, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- WHEN USING
- STOP USE
- Keep out of reach of children.
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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
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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
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INGREDIENTS AND APPEARANCE
SEI BELLA TINTED BB MOISTURIZING CREME DEEP 550 N
titanium dioxide 5% and zinc oxide 5% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-290 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:54473-290-01 1 in 1 BOX 05/01/2018 1 NDC:54473-290-30 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(54473-290)
