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
ABELLA
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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.
https://otclabels.com/lib/otc/otc-meds/abella-color-shade-spf-35-ebony/