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

WhiteWater Advanced Brightening by

Drug Labeling and Warnings

WhiteWater Advanced Brightening by is a Otc medication manufactured, distributed, or labeled by H2O PLUS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Image of carton label wwa250.jpg

INGREDIENTS AND APPEARANCE

WHITEWATER ADVANCED BRIGHTENING  WHITEWATER ADVANCED BRIGHTENING SPF30
homosalate,oxybenzone,octisalate,avobenzone lotion

Product 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)