PROACTIV SPF 15- octinoxate, octisalate, and octocrylene liquid

Proactiv SPF 15 by

Drug Labeling and Warnings

Proactiv SPF 15 by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, KIK Holdco Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 6%
Octisalate 4%
Octocrylene 2%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

For external use only

Skin Cancer/Skin Aging Alert

spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

Inactive ingredients

water, polyglyceryl-3 laurate, safflower oil/palm oil aminopropanediol esters, oligopeptide-51, morus alba leaf extract, camellia sinensis leaf extract, hamamelis virginiana (witch hazel) bark/leaf/twig extract, panthenol, allantoin, tocopherol, bisabolol, hydroxymethoxyphenyl decanone, cetearyl clcohol, dicetyl phosphate, ceteth-20 phosphate, glycerin, dimethicone/vinyl dimethicone crosspolymer, acrylates/C10-30 alkyl acrylate crosspolymer, isoceteth-10, silica, butylene glycol, aminomethyl propanol, cyclopentasiloxane, ethylhexylglycerin, tetrasodium EDTA, citric acid, sodium hydroxide, phenoxyethanol, fragrance

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Within US 1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
proactiv.com ● Manufactured in Canada
Proactiv is a trademark of The Proactiv Company Sàrl

PRINCIPAL DISPLAY PANEL - 20 mL Tube Box

proactiv®        

LIQUID  SPF
SPF 15
SUNSCREEN
                 

0.75 FL. OZ. 20 mL

INGREDIENTS AND APPEARANCE

PROACTIV SPF 15 
octinoxate, octisalate, and octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	6 mg  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	4 mg  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate (UNII: G3232Z5S2O)
Safflower Oil (UNII: 65UEH262IS)
Morus Alba Leaf (UNII: M8YIA49Q2P)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Hamamelis Virginiana Bark (UNII: IH3063S9MY)
Panthenol (UNII: WV9CM0O67Z)
Allantoin (UNII: 344S277G0Z)
Tocopherol (UNII: R0ZB2556P8)
Levomenol (UNII: 24WE03BX2T)
Hydroxymethoxyphenyl Propylmethylmethoxybenzofuran (UNII: EZ6196NB0X)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Dihexadecyl Phosphate (UNII: 2V6E5WN99N)
Ceteth-20 Phosphate (UNII: 921FTA1500)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) (UNII: 9E4CO0W6C5)
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Isoceteth-10 (UNII: 1K92T9919H)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Butylene Glycol (UNII: 3XUS85K0RA)
Aminomethylpropanol (UNII: LU49E6626Q)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Ethylhexylglycerin (UNII: 147D247K3P)
Edetate Sodium (UNII: MP1J8420LU)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Hydroxide (UNII: 55X04QC32I)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-026-00	1 in 1 BOX	07/20/2015
1		20 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	07/20/2015

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Holdco Company Inc		243547333	manufacture(11410-026)