ABELLA SUNSCREEN TINTED SPF35 DARK- octinoxate, zinc oxide lotion 
Prime Enterprises Inc.

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.

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Abella Broad Spectrum SPF35 Tinted Sunscreen Lotion Dark

Active Ingredients

Octinoxate 3%

Zinc Oxide 3%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other information

Questions or comments?

Call toll free 1-877-622-3552

Principle Display Label

ABELLA  SUNSCREEN TINTED SPF35 DARK
octinoxate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30.3 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorbrown (Light beige/brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0500-360 mL in 1 TUBE; Type 0: Not a Combination Product08/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/16/2021
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0500) , manufacture(58443-0500) , label(58443-0500) , analysis(58443-0500)

Revised: 1/2022
Document Id: d579bb5f-1134-8dc4-e053-2995a90ad033
Set id: d579f28c-7a9e-3532-e053-2995a90a27c3
Version: 1
Effective Time: 20220113
 
Prime Enterprises Inc.