Label: SPECIFIC BEAUTY DAILY HYDRATING SPF 30- avobenzone,octocrylene,octinoxate,oxybenzone,octisalate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 52295-200-60 - Packager: Somabella Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 April 4, 2019
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- ACTIVE INGREDIENT
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- DESCRIPTION
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Inactive Ingredients
WATER (AQUA), CAPRYLYL METHICONE, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, NIACINAMIDE, STEARETH-21, CETEARYL ALCOHOL, GLYCERIN, ETHYLHEXYL METHOXYCRYLENE, ALUMINUM STARCH OCTENYL SUCCINATE, BORON NITRIDE, PHENOXYETHANOL, PHYLLANTHUS EMBLICA FRUIT EXTRACT BEHENYL ALCOHOL, POLYACRYLATE-13, POLYISOBUTENE, CETEARYL GLUCOSIDE, ARACHIDYL ALCOHOL ARACHIDYL GLUCOSIDE, XANTHAN GUM, POLYSORBATE 20,
CHLORPHENESIN, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, TOCOPHERYL ACETATE, DISODIUM EDTA, PHOSPHOLIPIDS, LINOLEIC ACID PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE.
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPECIFIC BEAUTY DAILY HYDRATING SPF 30
avobenzone,octocrylene,octinoxate,oxybenzone,octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52295-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 24 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MYRISTYL TRISILOXANE (UNII: J7960S4R1T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NIACINAMIDE (UNII: 25X51I8RD4) STEARETH-21 (UNII: 53J3F32P58) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) PHENOXYETHANOL (UNII: HIE492ZZ3T) DOCOSANOL (UNII: 9G1OE216XY) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) XANTHAN GUM (UNII: TTV12P4NEE) POLYSORBATE 20 (UNII: 7T1F30V5YH) CHLORPHENESIN (UNII: I670DAL4SZ) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM (UNII: 7FLD91C86K) LINOLEIC ACID (UNII: 9KJL21T0QJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52295-200-60 60 mL in 1 PACKAGE; Type 0: Not a Combination Product 01/20/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/20/2011 Labeler - Somabella Laboratories, LLC (877094925)