WHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30- homosalate,oxybenzone,octisalate,avobenzone lotion 
H2O PLUS

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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Drug Facts


Avobenzone 3.0%
Homosalate 8.0%
Octisalate 4.0%
Oxybenzone 5.0%

Sunscreen
Sunscreen
Sunscreen
Sunscreen

• Helps prevent sunburn
• If used as directed with other sun protection measures
(see directions) decreases the risk of skin cancers and early skin aging

• For external use only • Do not use on damaged or broken skin
• Stop use and ask a doctor if rash occurs

Keep out of eyes, Rinse with water to remove. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

• For Sunscreen use
• Apply liberally 15 minutes before sun exposure
• Use water resistance sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: Ask a doctor

Protect the product in this container from excessive heat
and direct sun

Aqua/Water/Eau, Alpha-Isomethyl Ionone, Ascophyllum Nodosum Extract, Ascorbyl
Glucoside, Benzyl Benzoate, Benzyl Salicylate, Butylene Glycol, Butylphenyl
Methylpropional, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside,
Citronellol, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexylglycerin,
Fragrance (Parfum), Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium
Acryloyldimethyl Taurate Copolymer, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde,
Isohexadecane, Laminaria Digitata Extract, Limonene, Linalool, Magnesium Chloride,
Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, Morus
Bombycis Root Extract, PEG-100 Stearate, Phenoxyethanol, Plankton Extract,
Polysorbate 60, Propylene Glycol, Saxifraga Sarmentosa Extract, Scutellaria
Baicalensis Root Extract, Sodium Metabisulfite, Sodium Sulfite, Sorbitan Isostearate,
Spirulina Maxima Extract, Tocopheryl Acetate, Triethanolamine, Trisiloxane, Vitis
Vinifera (Grape) Fruit Extract, Xanthan Gum

Image of carton label wwa250.jpg
Image of Carton Label

WHITEWATER ADVANCED BRIGHTENING  WHITEWATER ADVANCED BRIGHTENING SPF30
homosalate,oxybenzone,octisalate,avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mL  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate8 mL  in 100  mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate4 mL  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
BENZYL BENZOATE (UNII: N863NB338G)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CITRONELLOL ACETATE, (S)- (UNII: 78RZL4H51H)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETIC ACID (UNII: 9G34HU7RV0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MORUS AUSTRALIS ROOT (UNII: 1VL55O45RF)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TRIETHANOLAMINE HYDROCHLORIDE (UNII: R297UJ9QDY)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
VITIS VINIFERA FLOWERING TOP (UNII: 6TG3V35HTV)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65903-250-011 in 1 CARTON
138 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2012
Labeler - H2O PLUS (807722947)

Revised: 9/2011
Document Id: 85527fb2-ccec-4fbd-b0a7-c44eeeee018f
Set id: 146cd569-f4c5-4a78-8cae-97dfc6a568d7
Version: 1
Effective Time: 20110929
 
H2O PLUS