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 with SPF 15

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Octinoxate 7.5%
Octisalate 5.0%
Oxybenzone 3.0%		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.

OTC - WHEN USING SECTION

Avoid contact with eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - STOP USE SECTION

Discontinue use if irritation or rash appears.

Inactive Ingredients

water (aqua), ethylhexyl palmitate, isostearyl neopentanoate, propylene glycol, stearic acid, propylene glycol stearate SE, glycerin, talc, dimethicone, cetyl alcohol, magnesium ascorbyl phosphate, tocopherol, ascorbyl palmitate, sodium hyaluronate, lecithin, xanthan gum, sorbitan stearate, magnesium aluminum silicate, acrylates/C10-30 alkyl acrylate crosspolymer, simethicone, ammonium polyacrylate, triethanolamine, disodium EDTA, phenoxyethanol, methylparaben, propylparaben, butylparaben, methylisothiazolinone. 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

non-comedogenic

SPF
15

fragrance-free

1.7 FL. OZ. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
PROACTIV SHEER TINT MOISTURE   SPF 15
octinoxate, octisalate, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-711
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  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:11410-711-275 mL in 1 TUBE; Type 0: Not a Combination Product11/01/200801/01/2019
2NDC:11410-711-171 in 1 BOX11/01/200801/01/2019
250 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 finalpart35211/01/200801/01/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
Document Id: fe39b97f-eaf0-4390-a8d4-753cb28b60d6
Set id: 66a04b0b-1e34-412c-b0f9-7721bd6e9df3
Version: 2
Effective Time: 20200114
 
THE PROACTIV COMPANY LLC