Label: E-KO SKIN CARE SPF 50- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 73618-001-01 - Packager: E-Ko Beach Life Limited
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated April 5, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
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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
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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
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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
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INGREDIENTS AND APPEARANCE
E-KO SKIN CARE SPF 50
zinc oxide lotionProduct 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)
