Label: ABELLA SUNSCREEN TINTED SPF35 MEDIUM- octinoxate, zinc oxide lotion
- NDC Code(s): 58443-0499-3
- 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 13, 2022
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- 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
-
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, Hexyl Laurate, Hydrogenated Castor Oil, Iron Oxides, Isocetyl Stearate, Octyl Stearate, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sodium Chloride, Titanium Dioxide, Tocopheryl Acetate, Triethoxycaprylylsilane, Water
- Other information
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- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ABELLA SUNSCREEN TINTED SPF35 MEDIUM
octinoxate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0499 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 30.4 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 30.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CHLORIDE (UNII: 451W47IQ8X) FERRIC OXIDE RED (UNII: 1K09F3G675) CYCLOMETHICONE 6 (UNII: XHK3U310BA) DMDM HYDANTOIN (UNII: BYR0546TOW) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) ALMOND OIL (UNII: 66YXD4DKO9) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENTONITE (UNII: A3N5ZCN45C) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARAMEL (UNII: T9D99G2B1R) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) CHOLECALCIFEROL (UNII: 1C6V77QF41) ISOCETYL STEARATE (UNII: 3RJ7186O9W) OCTYL STEARATE (UNII: 772Y4UFC8B) DIMETHICONE 100 (UNII: RO266O364U) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) HEXYL LAURATE (UNII: 4CG9F9W01Q) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color brown (Dark Beige) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0499-3 60 mL in 1 TUBE; Type 0: Not a Combination Product 08/16/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/16/2021 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0499) , manufacture(58443-0499) , label(58443-0499) , analysis(58443-0499)
