Proactiv® Solution Oil Free Moisture SPF 15 Moisturizer

Proactiv Solution Oil Free Moisture SPF 15 Moisturizer by

Drug Labeling and Warnings

Proactiv Solution Oil Free Moisture SPF 15 Moisturizer by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV SOLUTION OIL FREE MOISTURE SPF 15 MOISTURIZER- octinoxate and zinc oxide lotion 
THE PROACTIV COMPANY LLC

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.

----------

Proactiv® Solution Oil Free Moisture SPF 15 Moisturizer

This light, luxurious lotion with SPF 15 is specially formulated to help protect acne-prone skin from the sun's harmful rays. The advanced moisturizing agents keep skin feeling soft and hydrated.

Directions

Apply to clean face and neck at least once daily. Use alone or under makeup. Apply prior to sun exposure.

Warnings

For external use only.

When using this product keep out of eyes. If contact occurs, rinse with water to remove.

If skin irritation or rash develops, discontinue use.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Centre immediately.

Keep out of reach of children.

For children under 6 months of age, ask a doctor.

Store at room temperature.

Medicinal ingredients

octinoxate 7.5%, zinc oxide 2.85%

Non medicinal ingredients

water (aqua/eau), diethylhexyl sebacate, cyclopentasiloxane, propylene glycol, hydroxypropyl starch phosphate, cyclohexasiloxane, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, ceteareth-20, nylon-12, aluminum starch octenylsuccinate, acrylates/C10-30 alkyl acrylate crosspolymer, xanthan gum, triethoxycaprylylsilane, sodium hydroxide, disodium EDTA, methylisothiazolinone, phenoxyethanol

Do not use if safety seal is broken or missing.

PRINCIPAL DISPLAY PANEL - 75 mL Tube Label

Rodan & Fields
proactiv®
SOLUTION

OIL FREE
MOISTURE

SPF 15 Moisturizer

DIN: 02247980

75 mL 2.5 FL. OZ.

Principal Display Panel - 75 mL Tube Label
PROACTIV SOLUTION OIL FREE MOISTURE SPF 15 MOISTURIZER 
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-017-1130 mL in 1 TUBE; Type 0: Not a Combination Product01/01/200712/31/2019
2NDC: 11410-017-171 in 1 BOX01/01/200712/31/2019
250 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC: 11410-017-2175 mL in 1 TUBE; Type 0: Not a Combination Product01/01/200712/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/200712/31/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 4/2013
Document Id: f1495d41-8175-4f3d-917c-20be2569f074
Set id: b0e7e677-e3ea-4c06-862f-7cc780c65dc8
Version: 2
Effective Time: 20130410