NEW HAWAIIAN TROPIC SENSITIVE SKIN LOTION SUNSCREEN- avobenzone and octocrylene and oxybenzone spray

New Hawaiian Tropic Sensitive Skin Lotion Sunscreen by

Drug Labeling and Warnings

New Hawaiian Tropic Sensitive Skin Lotion Sunscreen by is a Otc medication manufactured, distributed, or labeled by Accra-Pac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

New Hawaiian Tropic Sensitive Skin Lotion Spray Sunscreen

Drug Facts

Active ingredients

Avobenzone 3%

Octocrylene 8%

Oxybenzone 6%            

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

• For external use only
  
• Do not spray directly into face
  
• Flammable do not use near heat, flame or while smoking

While using this product

• Avoid spraying in eyes. If contact occurs rinse thoroughly with water.
  
• Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Stop use and ask a doctor

if irritation or rash develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison control center right way.

Directions

• Shake well before use
  
• Apply generously and evenly to all areas 15 minutes before sun exposure
  
• Spray on hands to apply to face
  
• Use in well-ventilated area
  
• Reapply at frequent intervals and after swimming or towel drying
  
• Ask a doctor before use on children under six months of age

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

• May stain some fabrics.

Inactive Ingredients

Water, Dimethyl Ether, Butyloctyl Salicylate, Ethylhexyl Benzoate, Hydrogenated Dimer Dilinoleyl/Dimethylcarbonate Copolymer, Glycerin, Polymethylsilsesquioxane, Caprylyl Glycol, Ceteareth-25, Disodium Ethylene Dicocamide PEG-15 Disulfate, Dimethyl Capramide, Aloe Barbadensis Leaf Juice, Trocopherol, Retinyl Palmitate (vitamin A), Tocopheryl Acetate (vitamin E), Gossypium Herbaceum (cotton) seed extract, Stevia Rebaudiana leaf/stem extract, Tamanndus Indica Seed extract, Butylene Glycol, Pentylene glycol, BHT, Xanthan Gum, triethanolamine, Disodium EDTA, Phenoxyethanol, Hexylene Glycol, 

Questions or comments?

Call 1-800-NO UV Ray, Mon-Fri

Distributed by:
Tanning Research Laboratories, LLC
Ormond Beach, FL 32174
www.hawaiiantropic.com

Principal Display Panel

New Hawaiian Tropic
Sensitive Skin
Lotion Spray Sunscreen
Oil free
Hypoallergenic
Skin-nourishing antioxidants
50 UVB/SPF with UVA
SunSure Protection TM 
Protect Pamper Nourish
Net Wt. 6 oz (170g)

INGREDIENTS AND APPEARANCE

NEW HAWAIIAN TROPIC SENSITIVE SKIN LOTION SUNSCREEN 
avobenzone and octocrylene and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17630-2000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.08 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.06 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
LEVANT COTTON OIL (UNII: N5CFT140R8)
STEVIA LEAF (UNII: 6TC6NN0876)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
XANTHAN GUM (UNII: TTV12P4NEE)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17630-2000-1	170 g in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/04/2009

Labeler - Accra-Pac, Inc. (024213616)

Establishment
Name	Address	ID/FEI	Business Operations
Accra-Pac, Inc.		024213616	MANUFACTURE