Active Ingredient
Zinc oxide 24.5%
Sunscreen Agent
Powder
FDA Label NDC 61354-017
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 Powder (NDC 61354-017). 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, uses, warnings, directions, inactive ingredients:, other information, package, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun
Warnings
For external use only.
Do not use on damage or broken skin.
When using this product: Avoid inhalation.
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 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.
Children under 6 months: Ask a docstor
Sun Protection Measures. Spendign time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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
Inactive Ingredients:
Calcium Aluminunm Borosilicate, Silica, Ethylhexylglycerin, Sodium Dehydroacetate, Fragrance, Sea Salt, Ceramide NP, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extrat, Psidium Guajava Fruit Extract, Iron Oxides
Other Information
Protect this product from excessive heat and direct sun
Package
61354-017-01_uc (Art 050 Uni 1320 Uc)
61354-017-01_aw (Art 050 Lbl Wrp 160)
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