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Proactiv Solution

Guthy-Renker LLC.

Proactiv Solution Daily Protection Plus Sunscreen SPF 30


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Proactiv Solution

Proactiv Solution

AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11410-601
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 2 mg
HOMOSALATE Homosalate 5 mL
OCTINOXATE OCTINOXATE 7.5 mL
OCTISALATE OCTISALATE 5 mL
OXYBENZONE OXYBENZONE 5 mg

Inactive Ingredients

Ingredient Name Strength
water
MEDIUM-CHAIN TRIGLYCERIDES
SILICON DIOXIDE
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)
ALPHA-TOCOPHEROL ACETATE
VITAMIN A PALMITATE
ISONONYL ISONONANOATE
POLYSORBATE 60
Salicylic Acid
LINALOOL, (+/-)-
Farnesol
PHENOXYETHANOL
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
PROPYLPARABEN
isobutylparaben

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11410-601-41 112 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-06-07


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