PROACTIV SHEER TINT MOISTURE SPF 15- octinoxate, octisalate, and oxybenzone 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.

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Proactiv Solution Sheer Tint Moisture

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Octinoxate 7.5%, Octisalate 5%,
Oxybenzone 3%Sunscreen

Directions

Apply a small amount to entire face. Reapply as needed or after towel drying, swimming or excessive perspiration. May be worn alone or under make-up. For children under 6 months of age, consult a doctor.

Warnings

For external use only. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

water (aqua/eau), ethylhexyl palmitate, isostearyl neopentanoate, propylene glycol, stearic acid, propylene glycol stearate, glycerin, talc, dimethicone, magnesium ascorbyl phosphate, tocopherol, ascorbyl palmitate, sodium hyaluronate, lecithin, xanthan gum, cetyl alcohol, sorbitan stearate, magnesium aluminum silicate, acrylates/C10-30 alkyl acrylate crosspolymer, simethicone, triethanolamine, disodium EDTA, methylparaben, propylparaben, butylparaben, imidazolidinyl urea. may contain (+/-) : iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891)

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

Rodan & Fields

proactiv®
SOLUTION

Sheer Tint
Moisture
with SPF 15

non-comedogenic

fragrance-free

1.7 FL. OZ. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
PROACTIV SHEER TINT MOISTURE  SPF 15
octinoxate, octisalate, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-206
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-206-171 in 1 BOX02/01/200201/01/2019
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/200201/01/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
Document Id: bc168647-cd7d-4929-8f65-612bf625d37f
Set id: 6ccb7494-b644-4b3c-83a9-be34bef3ec68
Version: 2
Effective Time: 20200109
 
THE PROACTIV COMPANY LLC