Label: ABELLA COLOR SHADE SPF 35 DARK- octinoxate and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0196-3 - Packager: Prime Enterprises 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 January 17, 2020
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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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 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, Cyclomethicone, Disodium EDTA, DMDM Hydantoin, Hexyl Laurate, Hydrogenated Castor Oil, Iron Oxides, Isocetyl Stearate, Melanin, Octyl Stearate, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sodium Chloride, Titanium Dioxide, Tocopheryl Acetate, Water (Aqua)
- Other Information
- Questions or comments?
- Abella ColorShade SPF 35 Dark
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INGREDIENTS AND APPEARANCE
ABELLA COLOR SHADE SPF 35 DARK
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0196 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 29 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 29 mg in 1 mL Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALMOND OIL (UNII: 66YXD4DKO9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GREEN TEA LEAF (UNII: W2ZU1RY8B0) BENTONITE (UNII: A3N5ZCN45C) CARAMEL (UNII: T9D99G2B1R) CETYL DIMETHICONE 45 (UNII: IK315POC44) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) CHOLECALCIFEROL (UNII: 1C6V77QF41) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CYCLOMETHICONE (UNII: NMQ347994Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) HEXYL LAURATE (UNII: 4CG9F9W01Q) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) FERRIC OXIDE RED (UNII: 1K09F3G675) ISOCETYL STEARATE (UNII: 3RJ7186O9W) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM (UNII: 7FLD91C86K) OCTYL STEARATE (UNII: 772Y4UFC8B) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0196-3 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/01/2013 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0196) , manufacture(58443-0196) , label(58443-0196)
