MAUI NATURALS ALL NATURAL SUNSCREEN- zinc oxide lotion 
Hawaiian Classic Perfumes, Inc.

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.

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Hawaiian Classic Perfumes OTC Private Label Sunscreen - Maui Naturals All Natural Sunscreen

Maui Naturals All Natural Sunscreen Lotion SPF 30

front

(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 photo

(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

MAUI NATURALS ALL NATURAL SUNSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58918-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58918-002-0290 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/10/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/10/2014
Labeler - Hawaiian Classic Perfumes, Inc. (103409512)

Revised: 11/2019
Document Id: 97e6f84a-c119-438e-e053-2a95a90a642b
Set id: 1f9016b3-c773-4f02-a785-f712ee8c320b
Version: 4
Effective Time: 20191121
 
Hawaiian Classic Perfumes, Inc.