E-ko SKIN CARE SPF 50: Package Insert and Label Information

E-KO SKIN CARE SPF 50- zinc oxide lotion
E-Ko Beach Life Limited

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.

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.

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

image description
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 25 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALOE VERA LEAF
CAPRYLYL CAPRYLATE/CAPRATE
MACADAMIA OIL
KUKUI NUT OIL
POLYGLYCERYL-2 OLEATE
POLYHYDROXYSTEARIC ACID (2300 MW)
GLYCERIN
COCONUT OIL
CETYL DIMETHICONE 25
MAGNESIUM SULFATE, UNSPECIFIED FORM
HYDROGENATED METHYL ABIETATE
GALACTOARABINAN
PROPANEDIOL
POLYGLYCERYL-2 STEARATE
COFFEA ARABICA FRUIT
NONI FRUIT JUICE
ARTHROSPIRA PLATENSIS
RICE BRAN
ROSEMARY
SUNFLOWER SEED
MEDIUM-CHAIN TRIGLYCERIDES
APRICOT
VANILLA BEAN
MUSKMELON
CRANBERRY
BANANA
SANDALWOOD
ARABICA COFFEE BEAN
APPLE
COCONUT
SUNFLOWER OIL
TOCOPHEROL
PLUMERIA ALBA FLOWER
KAOLIN
1,2-HEXANEDIOL
CAPRYLHYDROXAMIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73618-001-01 89 mL in 1 TUBE None
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)

Revised: 04/2022 E-Ko Beach Life Limited

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