WhiteWater Advanced Brightening

Manufacturer
H2O PLUS
Effective date
2011-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:02

Label at a glance#

ProductWhiteWater Advanced Brightening WhiteWater Advanced Brightening SPF30
Active ingredientAvobenzone, Homosalate, Octisalate, Oxybenzone
Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


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

OTC - PURPOSE SECTION

Sunscreen
Sunscreen
Sunscreen
Sunscreen

OTC - WHEN USING SECTION

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

WARNINGS SECTION

• 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

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton label wwa250.jpg
Image of Carton Label
Image of Carton Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65903-250-012019-11-13C16284748780-197449f38-c2a5-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65903-250-01WhiteWater Advanced BrighteningWhiteWater Advanced Brightening SPF301 in 1 CARTONLOTION11
65903-250-01WhiteWater Advanced BrighteningWhiteWater Advanced Brightening SPF3038 mL in 1 BOTTLE, PUMPLOTION381

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65903-250WHITEWATER ADVANCED BRIGHTENING WHITEWATER ADVANCED BRIGHTENING SPF30 (HOMOSALATE,OXYBENZONE,OCTISALATE,AVOBENZONE) LOTION [H2O PLUS]1Legacy NDC, 2 package rows20120302_146cd569-f4c5-4a78-8cae-97dfc6a568d7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctisalateACTIVE INGREDIENT4X49Y0596W1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
HomosalateACTIVE MOIETYV06SV4M95S1
OctisalateACTIVE MOIETY4X49Y0596W1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW81
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
ASCOPHYLLUM NODOSUMINACTIVE INGREDIENT168S4EO8YJ1
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338G1
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TU1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
BUTYLPHENYL METHYLPROPIONALINACTIVE INGREDIENTT7540GJV691
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNA1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CITRONELLOL ACETATE, (S)-INACTIVE INGREDIENT78RZL4H51H1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV01
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDEINACTIVE INGREDIENTQUE43B9Z2Q1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E1
ISOMETHYL-.ALPHA.-IONONEINACTIVE INGREDIENT9XP4LC555B1
LAMINARIA DIGITATAINACTIVE INGREDIENT15E7C67EE81
LIMONENE, (+)-INACTIVE INGREDIENTGFD7C86Q1W1
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88E1
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O1
MAGNESIUM NITRATEINACTIVE INGREDIENT77CBG3UN781
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPN1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
MORUS AUSTRALIS ROOTINACTIVE INGREDIENT1VL55O45RF1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SAXIFRAGA STOLONIFERA LEAFINACTIVE INGREDIENTO3TMV4903H1
SCUTELLARIA BAICALENSIS ROOTINACTIVE INGREDIENT7J95K7ID2S1
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)INACTIVE INGREDIENT1DXE3F3OZX1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C1
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3G1
SPIRULINA MAXIMAINACTIVE INGREDIENT9K7IG15M0Q1
TRIETHANOLAMINE HYDROCHLORIDEINACTIVE INGREDIENTR297UJ9QDY1
TRISILOXANEINACTIVE INGREDIENT9G1ZW13R0G1
VITIS VINIFERA FLOWERING TOPINACTIVE INGREDIENT6TG3V35HTV1
waterINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65903-25065903-250-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 332 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8OINTMENT / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CTABLET / SUBLINGUAL2 mgExact identifier — unii candidate
43 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CSOLUTION / RESPIRATORY (INHALATION)0.3 %w/wExact identifier — unii candidate
43 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL BENZOATEBENZYL BENZOATEN863NB338GINJECTION, SOLUTION / INTRAMUSCULAR750 mgExact identifier — unii candidate
4 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0TABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CINJECTION / EPIDURAL0.05 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SOLUTION / TOPICAL0.5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSUSPENSION / AURICULAR (OTIC)0.06 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CINJECTION / PERIDURALNAExact identifier — unii candidate
43 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM SULFITESODIUM SULFITEVTK01UQK3GTABLET / ORAL5 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / VAGINAL100 mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM SULFITESODIUM SULFITEVTK01UQK3GCAPSULE / ORAL0.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
43 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
85527fb2-ccec-4fbd-b0a7-c44eeeee018f146cd569-f4c5-4a78-8cae-97dfc6a568d72011-09-29WarningsExact identifier
spl id: 85527fb2-ccec-4fbd-b0a7-c44eeeee018f
spl set id: 146cd569-f4c5-4a78-8cae-97dfc6a568d7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.