Label: SEI BELLA SKIN REFINING TINTED MOISTURIZER FAWN- titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 54473-249-01 - Packager: Melaleuca Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 April 28, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
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Inactive Ingredients
1,2-hexandiol, aloe barbadensis leaf juice, alumina, aminomethyl propanol, aqua (water/eau), beta-glucan, butylene glycol, butyrospermum parkii (shea butter), caprylic/capric tryglyceride, caprylyl glycol, carnosine, cetearyl alcohol, ceteth-10 phosphate, cetyl palmitate, cucumis sativus (cucumber) fruit extract, cyclopentasilloxane, dicetyl phosphate, disodium EDTA, ethylhexylglycerin, glycerin, glycine soja (soybean) oil, hydrogenated cottonseed oil, hydrogenated palm glycerides, iron oxides (CI77491, CI77492, CI77499), isostearic acid, lecithin, octyldodecyl neopentanoate, PEG/PPG-20/15 dimethicone, pentylene glycol, phenyl methicone, polyethylene, polyglyceryl-3, polyricinoleate, polyhydroxystearic acid, polymethylsilsesquioxane, polysorbate 60, polysorbate 80, potassium cetyl phosphate, propylheptyl caprylate, simethicone, stearic acid, tetrahexyldecyl ascorbate, tetrapeptide-21, titanium dioxide (CI77891), tocopheryl acetate, tremella fuciformis sporocarp extract, vitis vinifera (grape) leaf extract, xanthan gum
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SEI BELLA SKIN REFINING TINTED MOISTURIZER FAWN
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-249 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.866 g in 44.4 mL Inactive Ingredients Ingredient Name Strength 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM OXIDE (UNII: LMI26O6933) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SHEA BUTTER (UNII: K49155WL9Y) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARNOSINE (UNII: 8HO6PVN24W) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) CETYL PALMITATE (UNII: 5ZA2S6B08X) CUCUMBER (UNII: YY7C30VXJT) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) glycerin (UNII: PDC6A3C0OX) SOYBEAN OIL (UNII: 241ATL177A) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) ISOSTEARIC ACID (UNII: X33R8U0062) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C) PENTYLENE GLYCOL (UNII: 50C1307PZG) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) POLYSORBATE 60 (UNII: CAL22UVI4M) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) STEARIC ACID (UNII: 4ELV7Z65AP) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TETRAPEPTIDE-21 (UNII: 179JUC43HU) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G) VITIS VINIFERA LEAF (UNII: R1H893D80E) XANTHAN GUM (UNII: TTV12P4NEE) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-249-01 1 in 1 BOX 1 44.4 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2013 Labeler - Melaleuca Inc. (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca Inc. 079287544 manufacture(54473-249)
