Otc - Active Ingredient
Active IngredientsOctinoxate 6%Oxybenzone 2%
Wet N Wild
FDA Label NDC 12027-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Markwins Beauty Products, Inc for the product Wet N Wild (NDC 12027-104). 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, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, 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
Indications & Usage
Use• Helps prevent sunburn
Directions • apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • children under 6 months: Ask a doctor
Directions • apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • children under 6 months: Ask a doctor
Warnings
WarningsSkin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or skin aging.For external use only.Do not use on damaged or broken skinWhen using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
Inactive Ingredients/Ingredients inactifsWater/Eau, Butylene Glycol, Isopropyl Myristate, Isododecane, Glyceryl Stearate SE, Triethanolamine, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Stearate, Talc, Stearic Acid, Sorbitan Sesquioleate, Triacontanyl PVP, Cetyl Palmitate, Alumina, Xanthan Gum, Acrylates Copolymer, Tridecyl Trimellitate, Chlorphenesin, Tocopheryl Acetate, Sodium Laureth Sulfate, Aloe Barbadensis Leaf Juice, Dipotassium Glycyrrhizate, Disodium EDTA, Stearyl Glycyrrhetinate, Sodium Hyaluronate, Methylisothiazolinone(MAY CONTAIN/PEUT CONTENIR): Iron Oxides/CI 77491, CI 77492, CI 77499, Titanium Dioxide/CI 77891, Ultramarines/CI 77007 77891, Yellow 6 Lake/CI 15985, Yellow 10 Lake/CI 47005, Zinc Oxide/CI 77947)
Package Label.Principal Display Panel
Package Label
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