New Hawaiian Tropic Sensitive Skin Lotion Sunscreen

Dosage form: spray
Ingredients: AVOBENZONE 0.03g in 1g, OCTOCRYLENE 0.08g in 1g, OXYBENZONE 0.06g in 1g
Labeler: Accra-Pac, Inc.
NDC Code: 17630-2000

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.

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)

NEW HAWAIIAN TROPIC SENSITIVE SKIN LOTION SUNSCREEN 
avobenzone and octocrylene and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE0.03 g  in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE0.08 g  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:17630-2000-1170 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/04/2009
Labeler - Accra-Pac, Inc. (024213616)
Establishment
NameAddressID/FEIOperations
Accra-Pac, Inc.024213616MANUFACTURE

Revised: 03/2010
 
Accra-Pac, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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