Otc - Active Ingredient
Active Ingredient Purpose
Zinc Oxide 20% Sunscreen
Sunceutical Spf 50 Mineral Body Cream
FDA Label NDC 70157-368
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Baxter Laboratories Pty. Ltd. for the product Sunceutical Spf 50 Mineral Body Cream (NDC 70157-368). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children. If swallowfield, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs.
Warnings
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.
Dosage & Administration
Directions
- Apply liberally 15 minutes before sun exposure
- Children under 6 months of age: Ask a doctor
- 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 a Broad 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
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
Other Safety Information
Other information
- Protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Inactive ingredients
Water, Coco-Caprylate/Caprate, Isohexadecane, Caprylic/Capric Triglyceride, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxstearate, Isoamyl Laurate, Pentylene Glycol, Isododecane, Polyglyceryl- 3 Polyricinoleate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Magnesium Sulfate, Polyhydroxystearic Acid, Isostearic Acid, Fragrance, Disteardimonium Hectorite, Hydroxyacetophenone, Pongamia Pinnata Seed Extract, Propylene Carbonate, Saccharide Isomerate, Limonene, Linalool, Citric Acid, Sodium Citrate
Package Label.Principal Display Panel
Emma Lewisham
Sunceutical SPF 50
Mineral Body Cream
Zinc Oxide Mineral Sun-Active
Broad Spectrum SPF 50 Sunscreen
100 mL/ 3.4 FL. OZ.
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