NDC | 58918-001-02 |
Set ID | 50393ea8-09f8-4e4b-b15d-c77c0c557ef4 |
Category | HUMAN OTC DRUG LABEL |
Packager | Hawaiian Classic Perfumes, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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Maui Surfer Honey Natural Sunscreen Lotion SPF 30
(Front Label:)
Maui Surfer Honey - Natural Sunscreen - Broad Spectrum - SPF 30 - Water Resistant 80 Minutes - Eco/Reef Friendly - 3 fl oz - 90 mL
(Back Label:)
Drug Facts
Active Ingredient - Purpose
Zinc Oxide (20%) .......................................................................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 liberally 15 minutes before sun exposure
*re-apply:
*after 80 minutes of swimming or sweating
*immediately after towel drying AND at least every 2 hours.
*Sun Protection Measures. Spending time in the sun increases your riskof 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
*children under 6 months: Ask a doctor.
Inactive Ingredients: Aloe Barbadensis Leaf Juice, Capric Caprylic Triglycerides, Castor Oil, Ethyl Vanillin, Honey, Hydrogenated Methyl Abietate, Jojoba Oil, Magnesium Sulfate, Olive Oil, Orange Oil (Steam Distilled), Polyaminopropyl Biguanide, Polyglycerol-10 Laurate, Sorbitan Stearate, Sunflower Oil, Tocopherols (Vitamin E), Water.
Other Information: Contains no nano particles.
Protect this product from excessive heat and direct sun.
Maui Natural Organics
375 W. Kuiaha, No. 39 — Haiku, Maui 96708
Tel 808 575 2100 — www.MauiNaturalOrganics.com
7 54220 70950 1
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INGREDIENTS AND APPEARANCE
MAUI SURFER HONEY NATURAL SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58918-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALOE VERA LEAF (UNII: ZY81Z83H0X) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) TOCOPHEROL (UNII: R0ZB2556P8) OLIVE OIL (UNII: 6UYK2W1W1E) POLIHEXANIDE (UNII: 322U039GMF) ORANGE OIL, DISTILLED (UNII: H4QNH2ZN7A) SUNFLOWER OIL (UNII: 3W1JG795YI) JOJOBA OIL (UNII: 724GKU717M) ETHYL VANILLIN (UNII: YC9ST449YJ) HONEY (UNII: Y9H1V576FH) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58918-001-02 90 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 03/07/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/07/2014 Labeler - Hawaiian Classic Perfumes, Inc. (103409512)