Label: LIFECELL BROAD SPECTRUM SPF 30 MINERAL- octinoxate, zinc oxide cream
- NDC Code(s): 58443-0426-3
- Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated September 17, 2021
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 broad spectrum SPF 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-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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Inactive ingredients:
Aloe Barbadensis Leaf Juice, Bentonite, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Cholecalciferol, Cyclohexasiloxane, Cyclopentasiloxane, Disodium EDTA, DMDM Hydantoin, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Isocetyl Stearate, Melanin, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sodium Chloride, Titanium Dioxide, Tocopheryl Acetate, Triethoxycaprylylsilane, Water, Iron Oxides
- Other information
- Questions or comments?
- LifeCell Hydrating Antioxidant Medium BB Cream Broad Spectrum SPF 30 - 50 mL
-
INGREDIENTS AND APPEARANCE
LIFECELL BROAD SPECTRUM SPF 30 MINERAL
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0426 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 30.03 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 30.03 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALMOND OIL (UNII: 66YXD4DKO9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) BENTONITE (UNII: A3N5ZCN45C) DMDM HYDANTOIN (UNII: BYR0546TOW) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) HEXYL LAURATE (UNII: 4CG9F9W01Q) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALOE VERA LEAF (UNII: ZY81Z83H0X) CHOLECALCIFEROL (UNII: 1C6V77QF41) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETYL DIMETHICONE 150 (UNII: 5L694Y0T22) ISOCETYL STEARATE (UNII: 3RJ7186O9W) SODIUM CHLORIDE (UNII: 451W47IQ8X) CARAMEL (UNII: T9D99G2B1R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) D&C BLACK NO. 2 (UNII: 4XYU5U00C4) Product Characteristics Color brown (Nude) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0426-3 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/23/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/23/2015 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0426) , manufacture(58443-0426) , label(58443-0426) , analysis(58443-0426)