HYDRATING AND BALANCING MOISTURIZER SPF 15- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
Physicians Formula Inc

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.

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Drug Facts

Active Ingredients:  Avobenzone 3.00%, Homosalate 3.75%, Octisalate 2.50%, Octocrylene 2.75%, Oxybenzone 2.00%

When using this product, keep out of eyes.  Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children.




image of bottle

image of box

HYDRATING AND BALANCING MOISTURIZER  SPF 15
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31645-158
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate3.75 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2.5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.75 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31645-158-041 in 1 CARTON
155 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/15/2011
Labeler - Physicians Formula Inc (021261805)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Formula Inc825048945manufacture

Revised: 6/2011
Document Id: 0eef79f2-66f6-45d0-8b98-f47b3a5cca48
Set id: 0c4f8c9b-9cd4-4abf-acc0-8fc3936279a4
Version: 2
Effective Time: 20110621
 
Physicians Formula Inc