Label: WHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30- homosalate,oxybenzone,octisalate,avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 65903-250-01 - Packager: H2O PLUS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 29, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Avobenzone 3.0%
Homosalate 8.0%
Octisalate 4.0%
Oxybenzone 5.0%
• 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 occursKeep 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 doctorAqua/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 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30
homosalate,oxybenzone,octisalate,avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65903-250 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 3 mL in 100 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 8 mL in 100 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 4 mL in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 5 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:65903-250-01 1 in 1 CARTON 1 38 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2012 Labeler - H2O PLUS (807722947)
