Proactiv Solution Daily Protection Plus Sunscreen SPF 30

Proactiv Solution Daily Protection Plus Sunscreen by

Drug Labeling and Warnings

Proactiv Solution Daily Protection Plus Sunscreen by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL - 112 g Tube Carton

Rodan & Fields

proactiv®
SOLUTION

Daily Protection Plus
Sunscreen

non-comedogenic

SPF
30

provides UVA/UVB protection

for face and body

4 OZ. 112 g

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: 11410-405
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mg  in 0.1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 mg  in 0.1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 0.1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 0.1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mg  in 0.1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-405-41	112 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2004	12/31/2019
2	NDC: 11410-405-42	1 in 1 BOX	01/01/2004	12/31/2019
2	NDC: 11410-405-41	112 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11410-405-17	48 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2004	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2004	12/31/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 7/2010

Document Id: 92d5fae1-863f-4aa5-9001-82b017de24e8

34390-5

Set id: aae30d5c-186a-4d63-b4d7-09e4edc10f05

Version: 2

Effective Time: 20100707

 

THE PROACTIV COMPANY LLC