Otc - Active Ingredient
Homosalate 10.00%
Octisalate 3.00%
Octocrylene 2.00%
Zinc Oxide 13.30%
Miffy Tone Perfecting Spf Cushion Cream
FDA Label NDC 84326-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rbgroup Co., Ltd for the product Miffy Tone Perfecting Spf Cushion (NDC 84326-002). 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, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, 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
Sunscreen
Indications & Usage
Helps prevent sunburn
If used as directed with other sun protection ,easure (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Dosage & Administration
■ apply liberally 15 minutes before sun exposure
■ use a water resistant sunscreen if swimming or sweating.
■ reapply at least every 2 hours.
■ 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
Warnings
■ For external use only
■ Do not useon demaged or broken skin.
■ Stop use and ask a doctorif rash occurs.
■ When using this productkeep out of eyes. Rinse with water to remove.
■ Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.
Inactive Ingredient
Water, Butyloctyl Salicylate, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Niacinamide, Cyclopentasiloxane, Silica, Sodium Chloride, Polyhydroxystearic Acid, 1,2-Hexanediol, Triethoxycaprylylsilane, Disteardimonium Hectorite, Ceresin, Fragrance, Propylene Carbonate, Trihydroxystearin, Ethylhexylglycerin, Caprylyl Glycol, Butylene Glycol, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Centella Asiatica Extract, Sucrose Stearate, Iron Oxides (CI 77492), Cetearyl Alcohol, Iron Oxides (CI 77491), Tocopherol, Madecassoside, Madecassic Acid, Asiaticoside, Asiatic Acid
Other Safety Information
Protect the product in this container from excessive heat and direct sunlight
* Please review the disclaimer below.
