FDA.reportPublic FDA data

Proactiv+ Clarifying Night Cream

Manufacturer
Guthy-Renker LLC
Effective date
2015-05-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:27:59

Label at a glance#

ProductProactiv Plus Clarifying Night
Active ingredientSalicylic Acid
Label structure10 sections

Dosage and administration

cleanse the skin thoroughly before applying this product. cover the entire affected area with a thin layer one to three times daily. because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. if bothersome dryness or peeling occurs, reduce application to once a day or every other day. Sensitivity Test f...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1.0%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

for the management of acne.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

If irritation becomes severe.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • cleanse the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one to three times daily.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, ethylhexyl palmitate, cetearyl alcohol, PPG-12/SMDI copolymer, cyclopentasiloxane, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalane, chamomilla recutita (matricaria) flower extract, aleurites moluccana seed oil, retinol, sodium ascorbate, tocopherol, retinyl palmitate, ascorbic acid, panthenol, sodium hyaluronate, PEG-180, PEG-75, cetyl PEG/PPG-10/1 dimethicone, hexylene glycol, caprylic/capric triglyceride, propylene glycol, dimethicone, polysorbate 60, glyceryl stearate, PEG-100 stearate, dicetyl phosphate, ceteth-10 phosphate, sodium hydroxide, phenoxyethanol, methylparaben, ethylparaben, propylparaben, isobutylparaben, fragrance.

Questions or comments?

OTC - QUESTIONS SECTION

Within US 1-800-950-4695

SPL UNCLASSIFIED SECTION

Dist. by: Guthy-Renker® LLC • PO Box 14383
Palm Desert • CA 92255-4383

PRINCIPAL DISPLAY PANEL - 75 mL Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rodan & Fields
proactiv+

Clarifying
Night
Cream

2.5 FL. OZ. 75 mL

salicylic acid
acne treatment

PRINCIPAL DISPLAY PANEL - 75 mL Tube Box
PRINCIPAL DISPLAY PANEL - 75 mL Tube Box

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-03511410-035-28

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
Water059QF0KO0RIACT
Ethylhexyl Palmitate2865993309IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PPG-12/SMDI Copolymer1BK9DDD24EIACT
CYCLOMETHICONE 50THT5PCI0RIACT
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 mpa.s at 1%)86FQE96TZ4IACT
SqualaneGW89575KF9IACT
Hexylene GlycolKEH0A3F75JIACT
Dihexadecyl Phosphate2V6E5WN99NIACT
Ceteth-10 Phosphate4E05O5N49GIACT
ChamomileFGL3685T2XIACT
KUKUI NUT OILTP11QR7B8RIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
PanthenolWV9CM0O67ZIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
Dimethicone92RU3N3Y1OIACT
Ascorbic AcidPQ6CK8PD0RIACT
TocopherolR0ZB2556P8IACT
RetinolG2SH0XKK91IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
Sodium AscorbateS033EH8359IACT
POLYETHYLENE GLYCOL 8000Q662QK8M3BIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
Butylene Glycol3XUS85K0RAIACT
Sodium Hydroxide55X04QC32IIACT
Polysorbate 60CAL22UVI4MIACT
PhenoxyethanolHIE492ZZ3TIACT
MethylparabenA2I8C7HI9TIACT
Ethylparaben14255EXE39IACT
PropylparabenZ8IX2SC1OHIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
36575fd0-7268-422f-b7bf-4de5151001d517d75607-2e67-4623-b321-9d5f76641bfa2015-05-27WarningsExact identifier
spl id: 36575fd0-7268-422f-b7bf-4de5151001d5
spl set id: 17d75607-2e67-4623-b321-9d5f76641bfa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.