Label: MOISTURIZING FACIAL SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene,oxybenzone lotion
- NDC Code(s): 62673-164-03
- Packager: Neoteric Cosmetics, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 7, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Active Ingredients
- Active Ingredients
- Active Ingredients
- Active Ingredients
- Purpose
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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
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Directions
• After cleansing, apply product to face and neck
• 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 am-2 pm
• Wear long sleeved shirts, pants, hats and sunglasses.
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Inactive Ingredients
Water, C12-15 Alkyl Benzoate, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Dilaurate , Glycerin, Stearic Acid, Propylene Glycol, Sodium Hyaluronate, Hydrolyzed Glycosaminoglycans, Panthenol, Tocopheryl Acetate, Sorbitan Stearate, PEG-40 Stearate, Cetyl Alcohol, Dimethicone, Vinyl Dimethicone Crosspolymer, Silica, BHT, Triethanolamine, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Disodium EDTA, Carbomer
- Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MOISTURIZING FACIAL SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene,oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62673-164 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.03 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.1 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.05 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.07 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.05 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 100 STEARATE (UNII: YD01N1999R) GLYCERYL DILAURATE (UNII: MFL3ZIE8SK) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV) PANTHENOL (UNII: WV9CM0O67Z) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) PEG-40 STEARATE (UNII: ECU18C66Q7) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TROLAMINE (UNII: 9O3K93S3TK) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62673-164-03 1 in 1 CARTON 04/01/2016 12/31/2024 1 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/01/2016 12/31/2024 Labeler - Neoteric Cosmetics, Inc. (790615181) Establishment Name Address ID/FEI Business Operations Cosmetic Solutions, LLC 807907928 manufacture(62673-164)
