PROACTIVPLUS SPF PROTECTION SPF 15- octinoxate, octisalate, and octocrylene liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Octinoxate 6% Octisalate 4% Octocrylene 2%
Available from:
THE PROACTIV COMPANY LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - helps prevent sunburn
Authorization status:
OTC monograph final
Authorization number:
11410-034-55

PROACTIVPLUS SPF PROTECTION SPF 15- octinoxate, octisalate, and octocrylene liquid

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.

----------

Proactiv Liquid SPFSPF 15 Sunscreen

Drug Facts

Active ingredients

Octinoxate 6%

Octisalate 4%

Octocrylene 2%

Purpos e

Sunscreen

Us es

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

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

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

PROACTIVPLUS SPF PROTECTION SPF 15

octinoxate, octisalate, and octocrylene liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11410 -0 34

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O ctino xa te (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51)

O c tino xa te

6 mg in 10 0 mL

O ctisa la te (UNII: 4X49 Y0 59 6 W) (Octisalate - UNII:4X49 Y0 59 6 W)

O c tisa la te

4 mg in 10 0 mL

O cto crylene (UNII: 5A6 8 WGF6 WM) (Octo crylene - UNII:5A6 8 WGF6 WM)

O c to c ryle ne

2 mg in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Diiso stea ro yl Po lyg lyceryl-3 Dimer Dilino lea te (UNII: G3232Z5S2O)

Sa fflo wer O il (UNII: 6 5UEH26 2IS)

Mo rus Alba Lea f (UNII: M8 YIA49 Q2P)

Green Tea Lea f (UNII: W2ZU1RY8 B0 )

Ha ma melis Virg inia na Ba rk (UNII: IH30 6 3S9 MY)

Pa ntheno l (UNII: WV9 CM0 O6 7Z)

Alla nto in (UNII: 344S277G0 Z)

To co phero l (UNII: R0 ZB2556 P8 )

Levo meno l (UNII: 24WE0 3BX2T)

Hydro xymetho xyphenyl Pro pylmethylmetho xybenzo fura n (UNII: EZ6 19 6 NB0 X)

Ceto stea ryl Alco ho l (UNII: 2DMT128 M1S)

Dihexa decyl Pho spha te (UNII: 2V6 E5WN9 9 N)

Ceteth-2 0 Pho spha te (UNII: 9 21FTA150 0 )

Glycerin (UNII: PDC6 A3C0 OX)

Dimethico ne/vinyl Dimethico ne Cro sspo lymer ( so ft Pa rticle) (UNII: 9 E4CO0 W6 C5)

Ca rbo mer Interpo lymer Type A ( a llyl Sucro se Cro sslinked) (UNII: 59 TL3WG5CO)

Iso ceteth-10 (UNII: 1K9 2T9 9 19 H)

Silico n Dio xide (UNII: ETJ7Z6 XBU4)

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

Amino methylpro pa no l (UNII: LU49 E6 6 26 Q)

Cyclo methico ne 5 (UNII: 0 THT5PCI0 R)

Ethylhexylg lycerin (UNII: 147D247K3P)

Edeta te So dium (UNII: MP1J8 420 LU)

Citric Acid Mo no hydra te (UNII: 29 6 8 PHW8 QP)

So dium Hydro xide (UNII: 55X0 4QC32I)

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:11410 -0 34-55

1 in 1 BOX

0 7/20 /20 15

0 6 /30 /20 19

1

20 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt352

0 7/20 /20 15

0 6 /30 /20 19

THE PROACTIV COMPANY LLC

Labeler -

T HE PROACT IV COMPANY LLC (080216357)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

KIK Ho ldco Co mpany Inc

243547333

ma nufa c ture (11410 -0 34)

Revised: 12/2017

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