Abella Broad Spectrum SPF35 Tinted Sunscreen Lotion Medium

Abella by

Drug Labeling and Warnings

Abella by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ABELLA SUNSCREEN TINTED SPF35 MEDIUM- 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 Medium

Active Ingredients

Octinoxate 3%

Zinc Oxide 3%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

• 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

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-877-622-3552

ABELLA  SUNSCREEN TINTED SPF35 MEDIUM
octinoxate, zinc oxide lotion

Product 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)

Revised: 1/2022

Document Id: d578e12c-c245-fdd1-e053-2995a90af506

34390-5

Set id: d578e245-6f8d-2403-e053-2a95a90a2cdc

Version: 1

Effective Time: 20220113