HAWAIIAN TROPIC TANNING DRY SPF 6- avobenzone and octocrylene and oxybenzone oil

Hawaiian Tropic Tanning Dry SPF 6 by

Drug Labeling and Warnings

Hawaiian Tropic Tanning Dry SPF 6 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

Drug Facts

Active Ingredients

Avobenzone 0.005mL / 1mL

Octocrylene 0.035mL / 1mL

Oxybenzone 0.015mL / 1mL

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

When 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 away.

Directions

• 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

Mineral Oil, Ethylhexyl Palmitate, Diisopropyl Adipate, Isopropyl Myristate, Silica, Cocos Nucifera (Coconut) Oil, Fragrance, Theobroma Cacao (Cocoa) Seed Butter, Amyl Acetate, Aloe Barbadensis Leaf Extract, Plumeria Acutifolia (Plumerica) Flower Extract, Mangifera Indica (Mango) Fruit Extract, Psidium Guajava (Guava) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Passiflora Incarnata (Passionflower) Fruit Extract, Colocasia Antiquorum Root Extract, Tocopheryl Acetate (Vitamin E), Ascorbic Acid (Vitamin C), Retinyl Palmitate (Vitamin A).

Questions or Comments?

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

Distributed by:
TANNING RESEARCH
LABORATORIES, LLC
Ormond Beach, FL 32174
Made in U.S.A.

PRINCIPAL DISPLAY PANEL

NEW LOOK
HAWAIIAN
Tropic®
TANNING
Dry Oil
Clear Spray Sunscreen
exotic island botanicals
skin-nourishing antioxidants
ultra moisturizing
6
UVB/SPF
WITH UVA
Protect Pamper    Nourish
6 FL. OZ. (177 ml)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC TANNING DRY SPF 6 
avobenzone and octocrylene and oxybenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17630-2013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.005 mL  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.035 mL  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.015 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
COCONUT OIL (UNII: Q9L0O73W7L)
AMYL ACETATE (UNII: 92Q24NH7AS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PLUMERIA EXTRACT (UNII: LGC8P2PC4H)
GUAVA (UNII: 74O70D6VG0)
PAPAYA (UNII: KU94FIY6JB)
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CHOCOLATE (UNII: D9108TZ9KG)
MANGO (UNII: I629I3NR86)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17630-2013-1	177 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/20/2009

Labeler - Accra-Pac, Inc. (024213616)

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