Otc - Active Ingredient
Active Ingredients
Zinc Oxide 14% w/w
Purpose
Sunscreen
Daily Defence Mineral Sunscreen Spf 50 Fragrance Free Cream
FDA Label NDC 10028-035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ultraceuticals Pty Ltd for the product Daily Defence Mineral Sunscreen Spf 50 Fragrance Free (NDC 10028-035). 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, inactive ingredient, other safety information, 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 swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if
- skin rash occurs
Warnings
Warnings
Do not use
- on damaged or broken skin
- keep out of eyes. Rinse with water to remove
When using this product
For external use only
Dosage & Administration
Directions
- Shake well.
- apply liberally and evenly 15 minutes before sun exposure.
- reapply at least every 2 hours.
- use a water resistant sunscreen if swimming or sweating.
- children under 6 months of age: ask a doctor.
- Sun Protection Measures:
- limit time in the sun , especially between 10am-2pm.
- Wear long-sleeved shirts, pants, and sunglasses.
Spending time in the sun increases your risk of skin cancer and early skin aging. To reduce this risk, regularly use a sunscreen with a Broad Spectrum of 15 or higer and other sun protection measures, including:
Inactive Ingredient
Inactive ingredients: Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Isododecane, Lauryl PEG-8 Dimethicone, Caprylic/Capric Triglyceride, Niacinamide, Polymethylsilsesquioxane, Propanediol, Caprylyl Methicone, Dimethicone, Methylpropanediol, Isoamyl Laurate, Tridecyl Salicylate, Polyglyceryl-2 Dipolyhydroxystearate, Sodium Chloride, Caprylyl Glycol, Bisabolol, Lecithin, Allantoin, Phenylpropanol, caffeine, Carnosine.
Other Safety Information
Other information
Protect from excessive heat and direct sun. Stand upright, cap down.
Otc - Questions
Package Label.Principal Display Panel
Daily Defence
Ultraceuticals
Mineral Sunscreen SPF 50+ Fragrance free
75mL/ 2.54 fl. oz.
Mineral Sunscreen Spf 50 Frag Free (Pdm N370 075c2 Updated 1)
* Please review the disclaimer below.
