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Name:New Hawaiian Tropic Sensitive Skin Lotion Sunscreen
Manufacturer:Accra-pac, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


New Hawaiian Tropic Sensitive Skin Lotion Spray Sunscreen

NEW HAWAIIAN TROPIC SENSITIVE SKIN LOTION SUNSCREEN - avobenzone, octocrylene and oxybenzone spray 
Accra-Pac, 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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New Hawaiian Tropic Sensitive Skin Lotion Spray Sunscreen

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)

Principal Display Panel
Hawaiian Tropic Sensitive Skin Lotion Spray Sunscreen
50 UVB/SPF with UVA Net Wt 6 oz (170g)


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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 0.03 g  in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.08 g  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 0.06 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
CAPRYLYL GLYCOL  
ALOE VERA LEAF  
VITAMIN A PALMITATE  
.ALPHA.-TOCOPHEROL ACETATE, D-  
LEVANT COTTON OIL  
STEVIA LEAF  
BUTYLENE GLYCOL  
PENTYLENE GLYCOL  
BUTYLATED HYDROXYTOLUENE  
XANTHAN GUM  
TROLAMINE  
EDETATE DISODIUM  
PHENOXYETHANOL  
HEXYLENE GLYCOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17630-2000-1 170 g in 1 BOTTLE, SPRAY None

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 Operations
Accra-Pac, Inc. 024213616 MANUFACTURE

Revised: 03/2010 Accra-Pac, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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