Label: MOISTURIZING FACIAL SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene,oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 62673-164-03 - Packager: Neoteric 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 December 4, 2001
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 .03 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE .1 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE .05 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE .07 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE .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 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 FINAL part352 04/01/2016 Labeler - Neoteric Cosmetics, Inc. (790615181)
