Active Ingredient
Zinc Oxide 20%
Cream
FDA Label NDC 61354-030
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 61354-030). 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, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
Helps prevent sunburn
If uses as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only.
Do Not Use
on damaged or broken skin.
When Using This Product
keep out of eyes
Rinse with water to remove
Stop Use And Ask A Doctor If
rash occurs
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 at least every 2 hours
Use a water resistant sunscreen if swimming or sweating.
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 10am to 2 pm
Wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months: ask a doctor
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes, Polyglyceryl-3 Polyricinoleate, Lecithin, Glycerin, Isostearic Acid, Polyhydroxystearic Acid, Silica, Glyceryl Caprylate, Damask Rose Flower Extract, Sunflower Seed Oil, Leuconostoc/Radish Root Ferment Filtrate, Coco-Caprylate/Caprate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Aloe Vera Leaf Juice, Maltodextrin, Orris Leaf Cell Extract, Indian Walnut Seed Oil, Algae Extract, Alexandrian Laurel Seed Oil, Pumpkin Seed Oil, Squalane, Xanthan Gum, Tocopherol, Bisabolol, Pomegranate Seed Oil, Creosote Bush Extract, Sodium Hyaluronate, Ascorbyl Palmitate.
Primary Size 27Ml
61354-030-03 Aw Primary (Art Kyp714jar 003)
Primary 68Ml
61354-030-02_aw_primary (Art Kyp714jar 002)
Secondary 68Ml
61354-030-02_aw_secondary (Art 050 Uni 1148 Pd)
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