Active Ingredients
Zinc Oxide 22.40%
Moisturizer
FDA Label NDC 61354-048
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 61354-048). 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, otc - when using, otc - stop use, otc - 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 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 damaged or broken skin.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer an 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-2pm
- wear long-sleeved shirts, pants hats and sunglasses
- Children under 6 months of age: Ask a doctor.
Other Information
Proect this product from excessive heat and direct sun.
Inactive Ingredients
Water(Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Males (Apple) Fruit Extract, Coco-Glucoside, Lactobacillus Ferment, Rubus Idaeus(red Raspberry) Seed oil, Cocos Nucifera(Coconut) Liquid Endosperm, Curcuma Longa (Turmeric) Rhizomes Oil, Butyrospermum parkii nut Extract, Hydrolyzed Jojoba Esters, Tocopherol, Dipotassium Glycyrrhizate, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra(Licorice) Root Extract, Butylene Glycol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Caprylyl/Capryl Glucoside, Sclerotium Gum, Cetearyl Glucoside, Ethylhexylglycerin, Xantham Gum, Octyldodecanol, Tapioca Startch, Citric Acid, Sorbitan Oleate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, May contain +/- Iron Oxides (CI 77491, CI 77492).
Questions Or Comments?
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Package Label.Principal Display Panel
61354-048-01_aw (Art 100143)
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