Active Ingredient
Zinc Oxide 17%
Moisturizer
FDA Label NDC 61354-042
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 Moisturizer (NDC 61354-042). 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, stop use, keep out the 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 protection. Higher SPF gives more sunburn protection. 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.
Warnings
For external use only.
Do Not Use
Do not use on damage or broken skin.
When Using
When using this product keep out of eyes. Rinse with water to remove.
Stop Use
Stop use and ask a dosctor if rash occurs.
Keep Out The Reach Of Children
​Keep out the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: Ask a doctor.
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 thsi risk, regulary use a sunscreen with a Board Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m - 2 p.m. wear long - sleeved shirts, pants, hats, and sunglasses
Other Information
Protect the protect in this container from excessive heat and direct sun
Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Cetearyl Olivate, Glyceryl Stearate Citrate, Stearyl/Octyldodecyl Citrate Crosspolymer, Dimethicone, Camellia Japonica Seed Oil, Glycolipids, Trehalose, Pullulan, Agastache Mexicana Flower/Leaf/Stem Extract, Camellia Oleifera Leaf Extract, Glycine, Alanine, Serine, Threonine, Chamomilla Recutita (Matricaria) Flower Extract, Leuconostoc/Radish Root Ferment Filtrate, Polylysine, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Hydrogenated Lecithin, Silica, Xanthan Gum, Cetearyl Alcohol, Tocopheryl Acetate, Mica, Tocopheryl, Sclerotium Gum, Glycerin, Caprylhydroxamic Acid, Titanium Dioxide (CI 77891) (090-50132-000)
Package Label.Principal Display Panel
61354-042-01_aw (Art 400 50132 000)
61354-042-02_aw (Art 083 50132 000 Page 1)
61354-042-03_aw (Art 060 50132 000)
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