VIVITE AFTERCARE ENVIRONMENTAL PROTECTION SUNSCREEN SPF 30- octinoxate, octisalate and zinc oxide cream
Allergan, Inc.

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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Drug Facts

Active ingredients

Octinoxate 7.5%

Octisalate 4%

Zinc oxide 7.8%

Purpose

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 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
apply to all skin exposed to the sun
reapply at least every 2 hours
children under 6 months of age: 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 value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 AM - 2 PM
- wear long-sleeved shirts, pants, hats, and sunglasses

Other information

protect the product in this container from excessive heat and direct sun
Store at 68°-77°F (20°-25°C).
RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Allantoin; C12-15 Alkyl Benzoate; Cetyl Hydroxyethylcellulose (350000 MW); Diazolidinyl Urea; Dimethicone; Edetate Disodium; Glycerin; Glyceryl Monostearate; Iodopropynyl Butylcarbamate; Methyldibromo Glutaronitrile; Methylparaben; Polyoxyl 100 Stearate; Phenoxyethanol; Propylparaben; Purified Water; Steareth-100; Steareth-2; Tocopheryl Acetate; Triacontanyl PVP (WP-660); and Xanthan Gum

Questions or comments?

1.800.377.7790
M-F 6 AM - 4:30 PM Pacific Time
viviteskincare.com

VIVITE®

EXFOLIATES

HYDRATES

PROTECTS

RECOMMENDED
SKIN
CANCER
FOUNDATION
DAILY USE

AFTERCARE
ENVIRONMENTAL
PROTECTION
SUNSCREEN

BROAD SPECTRUM SPF 30

2.5 oz (75 g)

VIVITE AFTERCARE ENVIRONMENTAL PROTECTION SUNSCREEN SPF 30
octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0023-4383
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	75 mg in 1 g
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W)	octisalate	40 mg in 1 g
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)	zinc oxide	78 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
allantoin (UNII: 344S277G0Z)
alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)
cetyl hydroxyethylcellulose (350000 MW) (UNII: T7SWE4S2TT)
diazolidinyl urea (UNII: H5RIZ3MPW4)
dimethicone (UNII: 92RU3N3Y1O)
edetate disodium (UNII: 7FLD91C86K)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
iodopropynyl butylcarbamate (UNII: 603P14DHEB)
methyldibromo glutaronitrile (UNII: YX089CPS05)
methylparaben (UNII: A2I8C7HI9T)
polyoxyl 100 stearate (UNII: YD01N1999R)
phenoxyethanol (UNII: HIE492ZZ3T)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
steareth-100 (UNII: 4OH5W9UM87)
steareth-2 (UNII: V56DFE46J5)
.alpha.-tocopherol acetate, D- (UNII: A7E6112E4N)
triacontanyl PVP (WP-660) (UNII: N0SS3Q238D)
xanthan gum (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0023-4383-25	1 in 1 CARTON	10/15/2011	06/30/2015
1		75 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0023-4383-32	907 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/15/2011	12/20/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/15/2011	06/30/2015

Labeler - Allergan, Inc. (144796497)

Name	Address	ID/FEI	Business Operations
Establishment
Ei, LLC		105803274	MANUFACTURE(0023-4383)

Revised: 9/2014

Document Id: a84cc145-308e-4cd3-a622-5e9fe1493b40

Set id: 779c91fc-90eb-4ffc-a3d8-0557ab91ee6e

Version: 2

Effective Time: 20140909

Allergan, Inc.