Label: DERMISA SUNSCREEN SPF 55 BROAD SPECTRUM- octinoxate, titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68343-003-04 - Packager: Montani Cosmetics Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 11, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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Directions
• apply 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 of 15 or higher and other sun protection measures including: • limit time in sun, especially from 10 a.m.- 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a Doctor
- Other information
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Inactive Ingredients
Behenyl Alcohol, BHT, Butyloctyl Salicylate, Caprylyl Methicone, Dimethicone, Dimethyl Capramide, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Ethylparaben, Fragrance, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Methylparaben, PEG-100 Stearate, Phenoxyethanol, Polyester-8, Propylparaben, Silica, Sodium Polyacrylate, Styrene/Acrylates Copolymer, Trideceth-6, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water, Xanthan Gum
- Package Label
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INGREDIENTS AND APPEARANCE
DERMISA SUNSCREEN SPF 55 BROAD SPECTRUM
octinoxate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68343-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.75 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) WATER (UNII: 059QF0KO0R) TRIDECETH-6 (UNII: 3T5PCR2H0C) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DOCOSANOL (UNII: 9G1OE216XY) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ETHYLPARABEN (UNII: 14255EXE39) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) PROPYLPARABEN (UNII: Z8IX2SC1OH) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68343-003-04 118 mL in 1 TUBE; Type 0: Not a Combination Product 09/08/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/08/2017 Labeler - Montani Cosmetics Inc (124852331)
