Drug Labeling and Warnings

Drug Details

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HAWAIIAN TROPIC- octocrylene, oxybenzone oil 
Edgewell Personal Care Brands LLC

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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Active Ingredients

Octocrylene 2%, Oxybenzone 4%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

Skin Cancer/Skin aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn not skin cancer or early skin aging

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.

May stain some fabrics.

Directions

Apply liberally 15 minutes before sun exposure Reapply: after 80 minutes of swimming or sweating

immediately after towel drying at least every 2 hours Children under 6 months: Ask a doctor

Inactive Ingredients

Ethylhexyl Palmitate, Mineral Oil, Diisopropyl Adipate, Isopropyl Myristate, Silica, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Amyl Acetate, Aloe Barbadensis Leaf Juice, PEG-8 Dimethicone, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Octyldodecanol, Retinyl Palmitate, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Fragrance.

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments?

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

Front Label

HAWAIIAN

Tropic

DARK TANNING

Oil

SPF 6

6

water resistant (80 minutes)

exotic island botanicals

a rare blend of nature's rich oils

indulge Pamper Nourish

6335412116

HAWAIIAN TROPIC 
octocrylene, oxybenzone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63354-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCOA BUTTER (UNII: 512OYT1CRR)  
MINERAL OIL (UNII: T5L8T28FGP)  
AMYL ACETATE (UNII: 92Q24NH7AS)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
MANGIFERA INDICA WHOLE (UNII: U34MFR958F)  
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)  
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)  
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63354-121-16236 g in 1 BOTTLE; Type 0: Not a Combination Product08/26/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/26/2011
Labeler - Edgewell Personal Care Brands LLC (151179769)

Revised: 11/2017
 
Edgewell Personal Care Brands LLC


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