LC Skincare - Ella Sunscreen Broad Spectrum SPF 55

Manufacturer
Cosmetic Solutions LLC
Effective date
2019-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:40

Label at a glance#

ProductLC Skincare - Ella Sunscreen Broad Spectrum SPF 55
Active ingredientOctinoxate, Zinc Oxide
Label structure10 sections

Indications and uses

Help prevent sunburn.

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. *Reapply: At least 80 minutes after 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 a broad spectrum SPF of 15 or higher and other sun protection measures including: l...

Storage and handling

Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Zinc Oxide 4.8%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Help prevent sunburn.

WARNINGS

WARNINGS SECTION

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 or irritation 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

DOSAGE & ADMINISTRATION SECTION

Apply liberally and evenly 15 minutes before sun exposure. *Reapply: At least 80 minutes after 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 a 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.

*For children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Manufactured/Distributed by:
LC Cell LLC
Sarasota, Florida 34236 U.S.A.

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LC
SKINCARE

Ella
Sunscreen
Broad Spectrum SPF55

e 1.7 fl. oz. (50 ml)
MADE IN USA

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-2614-22021-01-29C16284748780-1ba0f9c33-28ed-a910-e053-dadaa90a0b85LC Skincare - Ella Sunscreen Broad Spectrum SPF 55

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-2614-2LC Skincare - Ella Sunscreen Broad Spectrum SPF 5550 g in 1 BOTTLE, PUMPCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-2614LC SKINCARE - ELLA SUNSCREEN BROAD SPECTRUM SPF 55 (OCTINOXATE AND ZINC OXIDE) CREAM [COSMETIC SOLUTIONS LLC]1Legacy NDC, 1 package rows20191002_07ba6143-e469-422f-8838-7af3ea0a7839.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-261466163-2614-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1299c52c-d3f3-4e97-b43c-ba46a10b44e707ba6143-e469-422f-8838-7af3ea0a78392019-09-30WarningsExact identifier
spl id: 1299c52c-d3f3-4e97-b43c-ba46a10b44e7
spl set id: 07ba6143-e469-422f-8838-7af3ea0a7839

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.