BANANA BOAT MENS SPF 30- avobenzone,homosalate,octisalate,octocrylene,oxybenzone lotion 
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

Avobenzone 1.2%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 0.8%, Oxybenzone 4.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

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 help prevent sunburn, not skin cancer or early skin aging.

Warnings

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

Sun Protection Measures •Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m., wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Water, Stearyl Alcohol, Glycerin, Caprylyl Glycol, Hydrogenated Dimer Dilinoleyl/Dimethylcarbonate Copolymer, Phenoxyethanol, Cetyl Alcohol, Fragrance, Carbomer,Glyceryl Stearate, Methylparaben, Behenyl Alcohol, Xanthan Gum, Propylparaben, Sodium Lauroyl Sarcosinate, Sodium Hydroxide, Disodium EDTA, BHT, Disodium Ethylene Dicocamide PEG-15 Disulfate, Glyceryl Stearate Citrate, Cetearyl Alcohol, Sodium Lauroyl Lactylate, Lauryl PEG-8 Dimethicone, Methyl Dihydroabietate, Phenylisopropyl Dimethicone,Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Tocopherol, Tocopheryl Acetate, Lecithin, Aloe Barbadensis Leaf Juice.

Other Information

protect this product from excessive heat and direct sun

Questions or Comments?

Call 1-800-SAFESUN, Mon-Fri

BANANA

BOAT

FOR

MEN

TRIPLE DEFENSE

sunscreen lotion

30

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 30

ActiveProtect Technology

Combats Odor

Hydrates Skin

Water resistant (80 Minutes)

swim splash sport

63354280216335428014

BANANA BOAT MENS  SPF 30
avobenzone,homosalate,octisalate,octocrylene,oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-280
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.8 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63354-280-2160 g in 1 TUBE; Type 0: Not a Combination Product03/26/201412/31/2017
2NDC:63354-280-14177 g in 1 BOTTLE; Type 0: Not a Combination Product03/26/201412/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/26/201412/31/2017
Labeler - Edgewell Personal Care Brands LLC (151179769)

Revised: 11/2017
 
Edgewell Personal Care Brands LLC