FDA.reportPublic FDA data

e-ko SKIN CARE

Manufacturer
E-Ko Beach Life Limited
Effective date
2022-04-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:04

Label at a glance#

Producte-ko SKIN CARE SPF 50
Active ingredientZINC OXIDE
Label structure9 sections

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

Dosage and administration

• Apply generously 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 a broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit t...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Non-Nano Zinc Oxide 25.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

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 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 generously 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 a broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10am - 2pm • Wear long-sleeve shirts, pants, hats, and sunglasses

• Children under 6 months: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe Barbadensis Leaf Juice, Caprylyl Caprylate/Caprate, Macadamia Ternifolia Seed (Macadamia Nut) Oil, Aleurites Moluccana Seed (Kuki Nut) Oil, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Glycerin, Cocos Nucifera (Coconut) Oil, Cetyl Dimethicone, Magnesium Sulfate, Hydrogenated Methyl Abietate, Galactoarabinan, Propanediol, Polyglyceryl-2 Stearate, KonaRed® Hawaiian Coffee Fruit Extract, Morinda Citrifolia Honey (Noni honey), Organic Morinda Citrifolia Fruit Juice (Noni), Arthrospira Platensis (Hawaiian Spirulina), Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Caprylic/Capric Triglyceride, Prunus Armeniaca (Apricot) Fruit Extract, Vanilla Planifolia Fruit Extract, Cucumis Melo Cantalupensis (Cantaloupe) Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Santalum Album (Sandalwood) Extract, Butter Extract, Coffea Arabica (Coffee) Leaf/ Seed Extract, Pyrus Malus (Apple) Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Plumeria Alba Flower Extract, Kaolin, Hydrogenated Vegetable Oil, 1,2-Hexanediol, Caprylhydroxamic Acid.

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

SAFE FOR MARINE LIFE.  SAFE FOR YOUR FACE AND YOUR BODY.  SAFE FOR REEFS

WATER RESISTANT 

80 MIN SUNSCREEN

BROAD SPECTRUM SPF 50+

NON- NANO ZINC OXIDE

SEVEN HAWAIIN ANTIOXIDANT INGREDIENTS

OCTINOXATE AND OXYBENZONE FREE

MANUFACTURED FOR

E-Ko Beach Life LLC

North Wales, PA

VISIT EKOBEACHLIFE.COM

MADE IN THE U.S.A

USING FOREIGN & DOMESTIC MATERIALS

POWERED BY Kokua Sun Care ®

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73618-001-012024-01-30C16284748780-1d6a99b39-5439-a426-e053-dadaa90af4c2e-ko SKIN CARE SPF 50
73618-001-012022-04-05C16284748780-1d6a99b39-5439-a426-e053-dadaa90af4c2e-ko SKIN CARE SPF 50
73618-001-012022-01-28C16284748780-1d6a99b39-5439-a426-e053-dadaa90af4c2e-ko SKIN CARE SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73618-001-01e-ko SKIN CARESPF 5089 mL in 1 TUBELOTION892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73618-001E-KO SKIN CARE SPF 50 (ZINC OXIDE) LOTION [E-KO BEACH LIFE LIMITED]2Legacy NDC, 1 package rows20220406_e5960f4e-b103-477b-9d90-80a43595130e.zip

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73618-00173618-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAPRYLYL CAPRYLATE/CAPRATE22MCG4RSMRIACT
MACADAMIA OIL515610SU8CIACT
KUKUI NUT OILTP11QR7B8RIACT
POLYGLYCERYL-2 OLEATE5759J47SAMIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
GLYCERINPDC6A3C0OXIACT
COCONUT OILQ9L0O73W7LIACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
HYDROGENATED METHYL ABIETATEA23O709X8OIACT
GALACTOARABINANSL4SX1O487IACT
PROPANEDIOL5965N8W85TIACT
POLYGLYCERYL-2 STEARATE253MC0P0YVIACT
COFFEA ARABICA FRUITHOX6BEK27QIACT
NONI FRUIT JUICE6ULF85Z07JIACT
ARTHROSPIRA PLATENSIS9L3TIH1UUEIACT
RICE BRANR60QEP13ICIACT
ROSEMARYIJ67X351P9IACT
SUNFLOWER SEEDR9N3379M4ZIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
APRICOT269CJD5GZ9IACT
VANILLA BEANQ74T35078HIACT
MUSKMELONZV095H5633IACT
CRANBERRY0MVO31Q3QSIACT
BANANA4AJZ4765R9IACT
SANDALWOOD3641YW25N2IACT
ARABICA COFFEE BEAN3SW678MX72IACT
APPLEB423VGH5S9IACT
COCONUT3RT3536DHYIACT
SUNFLOWER OIL3W1JG795YIIACT
TOCOPHEROLR0ZB2556P8IACT
PLUMERIA ALBA FLOWERLGC8P2PC4HIACT
KAOLIN24H4NWX5COIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT

Source Document#

Source XML · Source PDF

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
732bacd9-6353-40bb-b972-ebd7ca9d86d4e5960f4e-b103-477b-9d90-80a43595130e2022-04-05WarningsExact identifier
spl id: 732bacd9-6353-40bb-b972-ebd7ca9d86d4
spl set id: e5960f4e-b103-477b-9d90-80a43595130e

Reported adverse events (FAERS/openFDA)#

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