Otc - Active Ingredient
Active ingredient(s)
ZINC OXIDE 13.00%
HOMOSALATE 8.50%
ETHYLHEXYL SALICYLATE 4.50%
TITANIUM DIOXIDE 3.00%
Missha All Around Vita C Sunscreen Cream
FDA Label NDC 13733-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Able C&c Co., Ltd. for the product Missha All Around Vita C Sunscreen (NDC 13733-500). 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, inactive ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients
WATER, DISILOXANE, CYCLOPENTASILOXANE, BUTYLOCTYL SALICYLATE, ALCOHOL DENAT., POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, BUTYLENE GLYCOL, NIACINAMIDE, PROPANEDIOL, METHYL METHACRYLATE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, SILICA, SODIUM CHLORIDE, 1,2-HEXANEDIOL, 3-O-ETHYL ASCORBIC ACID, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, FRAGRANCE, MELIA AZADIRACHTA FLOWER EXTRACT, MELIA AZADIRACHTA LEAF EXTRACT, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, OCIMUM SANCTUM LEAF EXTRACT, ASCORBIC ACID, ETHYLHEXYLGLYCERIN, CORALLINA OFFICINALIS EXTRACT, SODIUM HYALURONATE, TOCOPHEROL
Otc - Purpose
Purpose
Sunscreen
Warnings
Warnings
■ For external use only.
■ Do not use on damaged or broken skin.
■ When using this product keep out of eyes. Rinse with water to remove.
■ Stop use and ask a doctor if rash occurs
■ Keep out of reach of children if product is swallowed, get medical help or contact a Poison Control Center right away.
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
Use(s)
■ 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
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 againg. To decrease this risk, regularly use a sunscreen with SPF value of 15 or higher and other sun protection measures including:
■ Limit time in the sun, especially from 10a.m.-2p.m.
■ Wear long-sleeved shirts, pants, hats and sunglasses
Other Safety Information
Other Information
■ Protect the product in this container from excessive heat and direct sun
Otc - Questions
Questions?
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