FDA.reportPublic FDA data

Proactiv

Manufacturer
THE PROACTIV COMPANY LLC | VEE PAK, LLC
Effective date
2017-12-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:06:33

Label at a glance#

ProductProactiv SPF 15 Moisturizer
Active ingredientOCTINOXATE, Zinc Oxide
Label structure8 sections

Indications and uses

▪  helps prevent sunburn ▪  if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: ▪...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Octinoxate 7.5
Zinc Oxide 3Sunscreen

Uses

INDICATIONS & USAGE SECTION

▪  helps prevent sunburn
▪  if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes.  Rinse with water to remove.                       

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: Ask a doctor

Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: ▪ limit time in the sun, especially from 10 a.m.-2 p.m. ▪  wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Diethylhexyl Sebacate, Cyclopentasiloxane, Propylene Glycol, Cetearyl Alcohol, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Cyclohexasiloxane, PEG-100 Stearate, Dimethicone, Phenoxyethanol, Ceteareth-20, Nylon-12, Aluminum Starch Octenylsuccinate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Triethoxycaprylylsilane, Sodium Hydroxide, Disodium EDTA, Methylisothiazolinone, BHT

Other information

▪ protect this product from excessive heat and direct sun 

Questions or comments?
Within US 1-800-950-4695

Distributed by The Proactiv Company, LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
Made in the USA of Foreign and Domestic Components
proactive.com
Proactiv is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv®            

OIL
FREE
MOISTURE

Broad Spectrum SPF 15

1 FL. OZ. 30 mL

non-comedogenic
dermatologist tested

Proactiv Oil Free Moisture SPF 15 Carton
Proactiv Oil Free Moisture SPF 15 Carton

PRINCIPAL DISPLAY PANEL - 89 mL Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv®

OIL
FREE
MOISTURE

Broad Spectrum SPF 15

3 FL. OZ. 89 mL

non-comedogenic
dermatologist tested

Proactiv Oil Free Moisture SPF 15 89 mL Tube
Proactiv Oil Free Moisture SPF 15 89 mL Tube

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
ZINCACTIVE MOIETYJ41CSQ7QDS2

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-60311410-603-11, 11410-603-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Diethylhexyl SebacateU9LS47Q72QIACT
Cyclomethicone 50THT5PCI0RIACT
Propylene Glycol6DC9Q167V3IACT
Cetostearyl Alcohol2DMT128M1SIACT
Glyceryl Monostearate230OU9XXE4IACT
Cyclomethicone 6XHK3U310BAIACT
Peg-100 StearateYD01N1999RIACT
Dimethicone92RU3N3Y1OIACT
PhenoxyethanolHIE492ZZ3TIACT
Polyoxyl 20 Cetostearyl EtherYRC528SWUYIACT
Nylon-12446U8J075BIACT
Xanthan GumTTV12P4NEEIACT
TriethoxycaprylylsilaneLDC331P08EIACT
Sodium Hydroxide55X04QC32IIACT
Edetate Disodium7FLD91C86KIACT
Methylisothiazolinone229D0E1QFAIACT
Butylated Hydroxytoluene1P9D0Z171KIACT
Hydroxypropyl Distarch Phosphate, High Amylose Corn9F8ET54T05IACT
Aluminum Starch OctenylsuccinateI9PJ0O6294IACT
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked)71DD5V995LIACT

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
d4de9093-1e64-40e0-8a7f-05c74540d1e61da41cf2-3d89-46dc-8d05-120a5a3134d02019-12-18WarningsExact identifier
spl set id: 1da41cf2-3d89-46dc-8d05-120a5a3134d0

Reported adverse events (FAERS/openFDA)#

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