Zinc Oxide 20% Lotion
FDA Label NDC 87223-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Beach Rooster for the product Zinc Oxide 20% (NDC 87223-001). 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 active ingredient purpose zinc oxide 20% .......................................................sunscreen, uses, directions, warnings for external use only., keep out of reach of children., inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Helps prevent sunburn . If used as directed with other
sun protection measures (see Directions), decreases the risk
of skin cancer and early skin aging caused by the sun.
Directions
Apply evenly to face and neck 15 minutes before sun
exposure reapply: After 80 minutes of swimming or sweating .
Immediately after towel drying . At least every 2 hours •
Sun Protection
Measures.Spending time in the sun increases your risk of skin cancer
and early skin aging. To decrease this risk, regularly use a sunscreen
with a Broad Spectrum SPF value of 15 or higher and other sun
protection measures including: Limit time in the sun, especially from
10a.m.– 2p.m. . Wear long-sleeve shirts, pants, hats, and sunglasses.
. Children under 6 months: Ask a doctor.
Warnings For External Use Only.
Do not useon damaged or broken skin.
When using this product• keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor ifrash occurs.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact Poison Control Center right away
Inactive Ingredients
Allantoin, Aloe Barbadensis Leaf Juice,
Butylene Glycol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea)
Butter, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl
Glyceryl Ether, Caprylyl Caprylate/Caprate, Cetearyl Olivate, Cucumis
Sativus (Cucumber) Seed Oil, Dicaprylyl Carbonate, Dimethicone,
Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Helianthus Annuus
(Sunflower) Seed Oil, Hydrogenated Castor Oil, lron Oxides (Cl 77491),
lron Oxides (Cl 77492), lron Oxides (Cl 77499), Isopropyl Myristate,
Jojoba Esters, Magnesium Sulfate, Niacinamide, Octyldodecanol,
Phenoxyethanol, Polyglyceryl-2 Laurate, Polyglyceryl-3-Polyricinoleate,
Polyhydroxystearic Acid, Propanedial, Sorbitan Olivate, Synthetic
Beeswax, Tocopheryl Acetate, Trihydroxystearin, VP/Hexadecene
Copolymer, Xanthan Gum, Water, Xanthan Gum
* Please review the disclaimer below.
