Label: HYDRATING AND BALANCING MOISTURIZER SPF 15- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 31645-158-04 - Packager: Physicians Formula 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 June 21, 2011
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
HYDRATING AND BALANCING MOISTURIZER SPF 15
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:31645-158 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 3 g in 100 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 3.75 g in 100 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 2.5 g in 100 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 2.75 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 2 g in 100 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Stearic Acid (UNII: 4ELV7Z65AP) Silicon Dioxide (UNII: ETJ7Z6XBU4) Panthenol (UNII: WV9CM0O67Z) Dimethicone (UNII: 92RU3N3Y1O) Butylene Glycol (UNII: 3XUS85K0RA) Edetate Disodium (UNII: 7FLD91C86K) Polysorbate 60 (UNII: CAL22UVI4M) Caprylyl Glycol (UNII: 00YIU5438U) Ethylhexylglycerin (UNII: 147D247K3P) Hexylene Glycol (UNII: KEH0A3F75J) Phenoxyethanol (UNII: HIE492ZZ3T) FD&C Blue No. 1 (UNII: H3R47K3TBD) Ext. D&C Violet No. 2 (UNII: G5UX3K0728) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:31645-158-04 1 in 1 CARTON 1 55 g in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/15/2011 Labeler - Physicians Formula Inc (021261805) Establishment Name Address ID/FEI Business Operations Physicians Formula Inc 825048945 manufacture