Active Ingredients
Zinc Oxide 20%
Cream
FDA Label NDC 61354-033
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 61354-033). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use, 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
Help prevent sunburns
if used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.
Warnings
For external use only.
Do Not Use
Do not use on damaged on broken skin.
When Using This Product
When using this product, keep out of eyes. Rinse with water to remove.
Stop Use
stop use and ask a doctor if rash occurs
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Directions
Apply liberally 15 minutes before sun exposure.
Reapply at least every two hours
Use a water resistant sunscreen if swimming or sweating.
Sun Protection Measures. Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Board Spectrum SPF value 15 or higher and other sun protection measure including:
Limit time in the sun, especially from 10am to 2 pm
Wear long-sleeved shirt, 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 Ingredient
Water/Aqua, Caprylic/Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes, Glycerin, Polyglyceryl-3 Polyricinoleate, Silica, Glyceryl Caprylate, Lecithin, Rose (Rosa Damascena) Flower Extract, Algae, Aloe (Aloe Barbadensis) Leaf Juice, Isostearic Acid, Polyhydroxystearic Acid, Sunflower (Helianthus Annuus) Seed Oil, Sweet Iris (Iris Pallida) Leaf Cell Extract, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Coco-Caprylate/Caprate, Kukui (Aleurites Moluccanus) Seed Oil, Pumpkin (Cucurbita Pepo) Seed Oil, Squalane, Xanthan Gum, Tamanu (Calophyllum Inophylum) Seed Oil, Pomegranate (Punica Granatum) Extract, Chaparral (Larrea Tridentata) Extract, Leuconostoc/Radish Root Ferment Filtrate, Bisabolol, Tocopherol, Sodium Hyaluronate, Citric Acid
Secondary Package
61354-033-01_aw (Art 050 Uni 806)
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