Active Ingredient
Zinc Oxide 24%
Cream
FDA Label NDC 61354-089
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oxygen Development Llc for the product Cream (NDC 61354-089). 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, uses, warnings, when using, keep out of reach of children, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
Help prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin caused by the sun.
Warnings
For external use only. Do not use on damaged or broken skin.
When Using
When using this product keep out of the eyes. rinse with water to remove.
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away
Directions
Apply liberally 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirt, pants, hat, and sunglasses. Children under 6 months: ask a doctor
Inactive Ingredient
Water/Aqua, C15-19 Alkane, Glycerin, Polyglyceryl-3 Polyricinoleate, Ethyl Macadamiate, Caprylic/Capric Triglyceride, Styrene/Acrylates Copolymer, Stearyl/Octyldodecyl Citrate Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Propanediol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, 1,2-Hexanediol, Hydroxyacetophenone, Magnesium Sulfate, Sodium Chloride, Caprylhydroxamic Acid, Tocopheryl Acetate, Sodium Hyaluronate, Tocopherol, Malic Acid
Other Information
Protect the product in this container from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number provided below.
Package Label
61354-089-01_aw (Art 050 Btl 1084)
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