Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 3.0% w/w Sunscreen
Homosalate 8.0% w/w Sunscreen
Octisalate 5.0% w/w Sunscreen
Octocrylene 7.0% w/w Sunscreen
Daily Defence Moisturising Sunscreen Broad Spectrum Spf 50 Cream
FDA Label NDC 10028-053
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 Moisturising Sunscreen Broad Spectrum Spf 50 (NDC 10028-053). 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 earlt 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 Contol Center right away.
Indications & Usage
Stop use and ask a doctor if
- 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
- Apply liberally and evenly 15 minutes before sun exposure
- Children under 6 months of age: ask a doctor
- Sun Protection Measures. Spending time int 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:
- reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
•Limit time in the sun, especially from 10 a.m. – 2 p.m.
•Wear long-sleeved shirts, pants hats, and sunglasses.
Inactive Ingredient
Inactive ingredients: Water/Aqua, Propanediol, Niacinamide, Methylpropanediol, Potassium Cetyl Phosphate, Microcrystalline Cellulose, Silica, Poly C10-30 Alkyl Acrylate, Cellulose, Caprylyl Methicone, Polysilicone-15, Stearyl Alcohol, Cetyl Alcohol, Caprylyl Glycol,Glycerin, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Panthenol, Carbomer, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Hibiscus Sabdariffa Fruit Extract, Hyaluronic Acid, Phenylpropanol.
Other Safety Information
Other information
Protect from excessive heat and direct sun
Package Label.Principal Display Panel
Daily Defense Moisturising Sunscreen SPF 50
Broad Spectrum Protection
75 mL/ 2.54 fl. oz.
Tube (1775694250057 Ad6c6be2 8347 4156 B463 90ac2aaacd06 1)
Carton (1775694250968 1172f0ed 77f8 4e1d 85fe 780c8b6debe0 1)
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