Otc - Active Ingredient
Zinc Oxide 12%,Titanium Dioxide 8%, Homosalate 12%, Octisalate4.5%,Phenylbenzimidazole Sulfonic Acid 3.5%
Sunscreen Cream
FDA Label NDC 84938-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foshan Sugar Max Cosmetics Co.,ltd for the product Sunscreen Cream (NDC 84938-007). 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, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, 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
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.
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf product is swallowed, get medical help or contact a Poison Control Center right away.May stain some fabrics.
Dosage & Administration
Directions apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating Immediately after towel drying "at least every 2 hours 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 timein the sun,especially from 10 a.m.-2 p.m."wear long-sleeved children under 6 months: shirts, pants, hats, and sunglassesAsk a doctor
Inactive Ingredient
Aqua (Water)
Caprylic/Capric Triglyceride
C12‑15 Alkyl Benzoate
Glycerin
Hydrogenated Poly(C6‑14 Olefin)
Polyhydroxystearic Acid
Polyglyceryl‑3 Polydimethylsiloxyethyl Dimethicone
Polyglyceryl‑6 Stearate
Polyglyceryl‑6 Behenate
Tocopherol
Beeswax
Xanthan Gum
Sodium Benzoate
Potassium Sorbate
Citric Acid
Package Label.Principal Display Panel
Label3 (Label3)
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