Whitewater Advanced Brightening
FDA Label NDC 65903-250
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H2o Plus for the product Whitewater Advanced Brightening (NDC 65903-250). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - when using, warnings, dosage & administration, storage and handling, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Otc - When Using
• 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
• 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.
Dosage & Administration
• 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
Protect the product in this container from excessive heat
and direct sun
Inactive Ingredient
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
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