Active Ingredient
Zinc Oxide 25%
Arnies Mineral Sunscreen - Broad Spectrum Spf 50 With Zinc Oxide Cream
FDA Label NDC 87237-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gimmie Botanicals Llc for the product Arnies Mineral Sunscreen - Broad Spectrum Spf 50 With Zinc Oxide (NDC 87237-001). 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, use, warnings, keep out of reach of children, directions, inactive ingredients, arnies mineral sunscreen - broad spectrum spf 50 with zinc oxide, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Use
- Helps prevent sunburn if used as directed with other sun protection measures. See Directions below.
- May decreases the risk of skincancer 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
- If swallowed, get medical help or contact a Poison Control Center immediately.
- Stop use and consult a doctor if rash occurs.
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Directions
- Apply liberal / 15 minutes before sun exposure.
- Reapply at least every two hours and immediately after towel drying.
- Use a water-resistant sunscreen if swimming or sweating.
- Consult a doctor before using with children under 6 months of age.
- 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 broad spectrum SPF value 15 or higher and other skin protection measures. These include limiting time in sun, especially from 10 am to 2 pm, and wearing long-sleeved shirts and pants, hats and sunglasses.
Inactive Ingredients
Water, Simmondsia Chinensis (Jojoba) Oil, Helianthus Annuus (Sunflower) Oil, Glycerin, Dimethicone, Cetearyl Alcohol, Caprylic Capric Triglyceride, Squalane, Ceramide NP, Cetearyl Glucoside, Hyaluronic Acid, Bisabolol, Organic Aloe Barbadensis Leaf Juice, Niacinamide, Tocopherol, Panthenol, Allantoin, Triethoxycaprylylsilane, Caprylyl Glycol, Xanthan Gum, Phenoxyethanol, CI 77491, CI 77492, and CI 77499 Iron Oxides.
Arnies Mineral Sunscreen - Broad Spectrum Spf 50 With Zinc Oxide
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