PROACTIV SOLUTION DAILY PROTECTION PLUS SUNSCREEN SPF 30- avobenzone, homosalate, octinoxate, octisalate, and oxybenzone cream
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 Daily Protection Plus Sunscreen SPF 30

Drug Facts

Active Ingredient

Avobenzone 2.0%, Homosalate 5.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 5.0%

Purpose

Sunscreen

Use

To protect against sun exposure

Warnings

For external use only

When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if skin irritation develops and lasts.

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

Directions

Apply liberally and evenly to all areas 15 minutes before sun exposure
Reapply as needed after swimming or towel drying.
For children under 6 months of age, consult a doctor.

Inactive Ingredients

water, neopentyl glycol diheptanoate, caprylic/capric triglyceride, trimethylpentanediol/adipic acid/glycerin crosspolymer, silica, sodium acrylate/sodium acryloyldimethyl taurate copolymer, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, isononyl isononanoate, salicylic acid, polysorbate 60, tocopheryl acetate, retinyl palmitate, linalool, farnesol, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben

Dist. By Guthy-Renker®
PO Box 14383
Palm Desert, CA 92255-4383

PRINCIPAL DISPLAY PANEL - 112 g Tube Label

Rodan & Fields
proactiv®
SOLUTION

DAILY PROTECTION
PLUS SUNSCREEN

non-comedogenic

SPF
30

provides UVA/UVB protection
for face and body

4 OZ. 112g

Principal Display Panel - 112 g Tube Label

PROACTIV SOLUTION DAILY PROTECTION PLUS SUNSCREEN SPF 30
avobenzone, homosalate, octinoxate, octisalate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11410-601
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mg in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 ug in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mg in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SALICYLIC ACID (UNII: O414PZ4LPZ)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FARNESOL (UNII: EB41QIU6JL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11410-601-41	112 g in 1 TUBE; Type 0: Not a Combination Product	06/07/2011	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	06/07/2011	12/31/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2012

Document Id: a18c39c5-0d08-4395-9b94-0f64e060a7be

Set id: e9a7a310-4b24-4e06-96c2-016528394e11

Version: 2

Effective Time: 20120123

THE PROACTIV COMPANY LLC