Label: MAUI NATURALS ALL NATURAL SUNSCREEN- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58918-002-02 - Packager: Hawaiian Classic Perfumes, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 November 21, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Maui Naturals All Natural Sunscreen Lotion SPF 30
(Front Label:)
Broad Spectrum - Maui Naturals - All Natural Sunscreen SPF 30 - Eco/Reef Friendly - no avo/oxybenzones - no petrochemicals - no nano particles - water resistant - 80 Min - with Maui Grown Essential Oils - 3 ounces /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 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 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, Hydrogenated Methyl Abietate, Jojoba Oil, Lemongrass Essential Oil, Magnesium Sulfate, Olive Oil, Polyaminopropyl Biguanide, Polyglycerol-10 Laurate, Rosemary Essential Oil, 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 70941 9
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INGREDIENTS AND APPEARANCE
MAUI NATURALS ALL NATURAL SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58918-002 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 SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) JOJOBA OIL (UNII: 724GKU717M) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) OLIVE OIL (UNII: 6UYK2W1W1E) ROSEMARY OIL (UNII: 8LGU7VM393) WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) SUNFLOWER OIL (UNII: 3W1JG795YI) TOCOPHEROL (UNII: R0ZB2556P8) POLIHEXANIDE (UNII: 322U039GMF) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58918-002-02 90 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 03/10/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/10/2014 Labeler - Hawaiian Classic Perfumes, Inc. (103409512)