ABELLA COLOR SHADE SPF 35 EBONY- octinoxate and 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 ColorShade Broad Spectrum SPF 35 Tinted Sunscreen Lotion Ebony

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, 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

Questions or comments?

Call toll free 1-877-622-3552

Abella ColorShade SPF 35 Ebony

Principal Display Image

ABELLA  COLOR SHADE SPF 35 EBONY
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE29.4 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE29.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 5 (UNII: 0THT5PCI0R)  
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)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
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
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0210-360 mL in 1 TUBE; Type 0: Not a Combination Product11/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/30/2015
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0210) , manufacture(58443-0210) , label(58443-0210)

Revised: 1/2020
Document Id: 9c589959-2e78-6216-e053-2995a90a74ff
Set id: 267f9ae8-ddfb-43c3-e054-00144ff88e88
Version: 3
Effective Time: 20200117
 
Prime Enterprises Inc.