Otc - Active Ingredient
Active Ingredients Purpose
Zinc Oxide 14% w/w................ Sunscreen
Ultra Uv Protective Daily Moisturising Spf 30 Mineral Sunscreen Cream
FDA Label NDC 10028-030
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 Ultra Uv Protective Daily Moisturising Spf 30 Mineral Sunscreen (NDC 10028-030). 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, package label.principal display panel, 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 product is 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.
When using this product
• keep out of eyes. Rinse with water
to remove.
For external use only.
Dosage & Administration
Directions
• Shake well.
• Apply liberally 15 minutes before sun
exposure.
reapply:
• 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 your time in the sun, especially
from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats,
and sunglasses
• after 40 minutes of swimming or
sweating
• immediately after towel drying
• at least every 2 hours
• Children under 6 months of age:
ask a doctor
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.
Package Label.Principal Display Panel
Ultraceuticals
Ultra UV Protective Daily Moisturisingg SPF 30 Mineral sunscreen Lotion
Broad Spectrum SPF 30
High Protection
Water Resistant
75 mL / 2.54 fl. Oz.
Lotion
* Please review the disclaimer below.
