OTC Medication Information: Abella Color Shade SPF 35 Ebony

ABELLA COLOR SHADE SPF 35 EBONY- zinc oxide and octinoxate 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.

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 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

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 ColorShade SPF 35 Ebony

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ABELLA COLOR SHADE SPF 35 EBONY
octinoxate and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0210
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 29.4 mg in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 29.4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE
SODIUM CHLORIDE
ALMOND OIL
SILICON DIOXIDE
GREEN TEA LEAF
BENTONITE
CARAMEL
CETYL DIMETHICONE 45
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
CHOLECALCIFEROL
HIGH DENSITY POLYETHYLENE
CYCLOMETHICONE 5
PROPYLENE GLYCOL
DMDM HYDANTOIN
HEXYL LAURATE
HYDROGENATED CASTOR OIL
FERRIC OXIDE RED
ISOCETYL STEARATE
CYCLOMETHICONE 6
WATER
ALOE VERA LEAF
ALPHA-TOCOPHEROL ACETATE
EDETATE DISODIUM
OCTYL STEARATE
POLYGLYCERYL-4 ISOSTEARATE
TRIETHOXYCAPRYLYLSILANE
Product Characteristics
Color brown Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58443-0210-3 60 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 11/30/2015
Labeler — Prime Enterprises Inc. (101946028)
Registrant — Prime Enterprises Inc. (101946028)
Establishment
Name Address ID/FEI Operations
Prime Enterprises Inc. 101946028 pack (58443-0210), manufacture (58443-0210), label (58443-0210)

Revised: 01/2020 Prime Enterprises Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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