E-KO SKIN CARE SPF 50- zinc oxide lotion

e-ko SKIN CARE by

Drug Labeling and Warnings

e-ko SKIN CARE by is a Otc medication manufactured, distributed, or labeled by E-Ko Beach Life Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Non-Nano Zinc Oxide 25.0%

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 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

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

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

INGREDIENTS AND APPEARANCE

E-KO SKIN CARE  SPF 50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73618-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT OIL (UNII: Q9L0O73W7L)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
GALACTOARABINAN (UNII: SL4SX1O487)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q)
NONI FRUIT JUICE (UNII: 6ULF85Z07J)
ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)
RICE BRAN (UNII: R60QEP13IC)
ROSEMARY (UNII: IJ67X351P9)
SUNFLOWER SEED (UNII: R9N3379M4Z)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
APRICOT (UNII: 269CJD5GZ9)
VANILLA BEAN (UNII: Q74T35078H)
MUSKMELON (UNII: ZV095H5633)
CRANBERRY (UNII: 0MVO31Q3QS)
BANANA (UNII: 4AJZ4765R9)
SANDALWOOD (UNII: 3641YW25N2)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
APPLE (UNII: B423VGH5S9)
COCONUT (UNII: 3RT3536DHY)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
PLUMERIA ALBA FLOWER (UNII: LGC8P2PC4H)
KAOLIN (UNII: 24H4NWX5CO)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73618-001-01	89 mL in 1 TUBE; Type 0: Not a Combination Product	03/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/25/2020

Labeler - E-Ko Beach Life Limited (117387123)