Indications and 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
Abella ColorShade Broad Spectrum SPF 35 Tinted Sunscreen Lotion Ebony
- Manufacturer
- Prime Enterprises Inc.
- Effective date
- 2020-01-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:03:00
Label at a glance#
ProductAbella Color Shade SPF 35 Ebony
Active ingredientZINC OXIDE, OCTINOXATE
Label structure9 sections
Dosage and administration
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 fr...
Contacts and useful links#
Label contents#
Full prescribing information#
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
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin
OTC - WHEN USING SECTION
When using this product keep out of eyes.
Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58443-0210-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-99a7-0266-e053-dadaa90a7c1a | Abella ColorShade Broad Spectrum SPF 35 Tinted Sunscreen Lotion Ebony |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58443-0210-3 | AbellaColor Shade SPF 35 Ebony | 60 mL in 1 TUBE | LOTION | 60 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58443-0210 | ABELLA COLOR SHADE SPF 35 EBONY (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES INC.] | 3 | Legacy NDC, 1 package rows | 20200118_267f9ae8-ddfb-43c3-e054-00144ff88e88.zip |
Products#
Every source-derived product name is available through these pages.
- Abella Color Shade SPF 35 Ebony
- Octinoxate and Zinc Oxide
- 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
- ZINC OXIDE
- OCTINOXATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58443-0210 | 58443-0210-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9c589959-2e78-6216-e053-2995a90a74ff | 267f9ae8-ddfb-43c3-e054-00144ff88e88 | 2020-01-17 | Warnings | 9c589959-2e78-6216-e053-2995a90a74ff 267f9ae8-ddfb-43c3-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.