Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 3% Sunscreen
Octinoxate 4% Sunscreen
Oxybenzone 3% Sunscreen
Zinc Oxide 4.5% Sunscreen
Correcting Cream Broad Spectrum Spf 15
FDA Label NDC 76261-126
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Australian Skin Products Pty Ltd for the product Correcting Cream Broad Spectrum Spf 15 (NDC 76261-126). 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 rash occurs.
Warnings
Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out eye. Rinse with water to remove.
Dosage & Administration
Directions
Apply liberally 15 minutes before sun exposure
Reapply: at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
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 15 or higher and other sun protection measures including:
Limit time in the sun especially from 10 a.m. - 2 p.m.
Wear long-sleeve Shirts, pants, hats and sunglasses
children under 6 months ask a doctor
Inactive Ingredient
Inactive ingredients: Water (Aqua), Methyl Gluceth-20, Caprylic/Capric Triglyceride, Butylene Glycol, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Triacontanyl PVP, Dimethicone, Citrus Tangerina (Tangerine) Peel Oil, Camellia Sinensis Leaf Extract, Punica Granatum (Pomegranate) Fruit Extract, Phenoxyethanol, Benzyl Alcohol, Triethanolamine, Ethylhexylglycerin, Propylene Glycol, Polysorbate 20, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499).
Package Label.Principal Display Panel
asap
the science of beautiful skin
correcting cream
with antixidants
hydrate + protect
Broad Spectrum SPF 15 sunscreen
75 mL/ 2.54 fl oz
Box Image (Cccream75ml Box July14)
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