Hydrating and Balancing Moisturizer SPF 15

Dosage form: lotion
Ingredients: Avobenzone 3g in 100g, Homosalate 3.75g in 100g, Octisalate 2.5g in 100g, Octocrylene 2.75g in 100g, Oxybenzone 2g in 100g
Labeler: Physicians Formula Inc
NDC Code: 31645-158

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 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.




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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone3 g  in 100 g
Homosalate (Homosalate) Homosalate3.75 g  in 100 g
Octisalate (Octisalate) Octisalate2.5 g  in 100 g
Octocrylene (Octocrylene) Octocrylene2.75 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Stearic Acid 
Silicon Dioxide 
Panthenol 
Dimethicone 
Butylene Glycol 
Edetate Disodium 
Polysorbate 60 
Caprylyl Glycol 
Ethylhexylglycerin 
Hexylene Glycol 
Phenoxyethanol 
FD&C Blue No. 1 
Ext. D&C Violet No. 2 
Packaging
#Item CodePackage Description
1NDC:31645-158-041 BOTTLE, PUMP (BOTTLE) 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/FEIOperations
Physicians Formula Inc825048945manufacture

Revised: 06/2011
 
Physicians Formula Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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