Proactiv Oil Free Moisture Broad Spectrum SPF 15

Proactiv by

Drug Labeling and Warnings

Proactiv by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, VEE PAK, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV  SPF 15 MOISTURIZER- octinoxate and zinc oxide lotion 
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 Oil Free Moisture Broad Spectrum SPF 15

Drug Facts

Active Ingredient	Purpose
Octinoxate 7.5
Zinc Oxide 3	Sunscreen

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

Warnings

For external use only

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

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

Directions

• 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

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

proactiv®           

OIL
FREE
MOISTURE

Broad Spectrum SPF 15

1 FL. OZ. 30 mL

non-comedogenic
dermatologist tested

PRINCIPAL DISPLAY PANEL - 89 mL Tube

proactiv®

OIL
FREE
MOISTURE

Broad Spectrum SPF 15

3 FL. OZ. 89 mL

non-comedogenic
dermatologist tested

PROACTIV   SPF 15 MOISTURIZER
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-603
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Diethylhexyl Sebacate (UNII: U9LS47Q72Q)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Cyclomethicone 6 (UNII: XHK3U310BA)
Peg-100 Stearate (UNII: YD01N1999R)
Dimethicone (UNII: 92RU3N3Y1O)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Nylon-12 (UNII: 446U8J075B)
Xanthan Gum (UNII: TTV12P4NEE)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Sodium Hydroxide (UNII: 55X04QC32I)
Edetate Disodium (UNII: 7FLD91C86K)
Methylisothiazolinone (UNII: 229D0E1QFA)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Hydroxypropyl Distarch Phosphate, High Amylose Corn (UNII: 9F8ET54T05)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) (UNII: 71DD5V995L)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-603-11	1 in 1 BOX	01/01/2007	12/02/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-603-00	89 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2007	12/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2007	12/02/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-603)

Revised: 12/2019

Document Id: d4de9093-1e64-40e0-8a7f-05c74540d1e6

34390-5

Set id: 1da41cf2-3d89-46dc-8d05-120a5a3134d0

Version: 4

Effective Time: 20191218