VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15- avobenzone, octisalate, and octocrylene cream

VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Northtec LLC, PADC 1, The Estee Lauder Inc, Whitman Laboratories Ltd., Estee Lauder N.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
avobenzone 3.00%	Sunscreen
octisalate 3.00%	Sunscreen
octocrylene 2.70%	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

For sunscreen use:

• apply generously and evenly 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• 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 10am – 2pm
  • wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

water\aqua\eau ethyl macadamiate butylene glycol methyl trimethicone hdi/trimethylol hexyllactone crosspolymer lauryl peg-9 polydimethylsiloxyethyl dimethicone peg-100 stearate butyloctyl salicylate jojoba esters glyceryl stearate barosma betulina leaf oil1, citrus paradisi (grapefruit) peel oil1, eucalyptus globulus (eucalyptus) leaf oil1, abies sibirica (pine) oil1, prunus amygdalus amara (bitter almond) kernel oil1, mentha arvensis (field mint) leaf oil1, rosa damascena (rose) oil1, limonene panax ginseng (ginseng) root extract cordyceps sinensis extract garcinia mangostana peel extract castanea sativa (chestnut) seed extract hordeum vulgare (barley) extract\extrait d'orge triticum vulgare (wheat) germ extract laminaria saccharina extract mangifera indica (mango) seed butter butyrospermum parkii (shea butter) caffeine citrus aurantium amara (bitter orange) flower water anthemis nobilis (chamomile) flower extract potassium cetyl phosphate glycerin cetyl alcohol isopropyl myristate trehalose ethylhexylglycerin linoleic acid squalane polymethyl methacrylate dehydroxanthan gum ascorbyl tocopheryl maleate glyceryl acrylate/acrylic acid copolymer sodium hyaluronate caprylyl glycol ammonium acryloyldimethyltaurate/vp copolymer citric acid stearic acid silica sodium dehydroacetate phenoxyethanol mica iron oxides (ci 77491, ci 77492, ci 77499) titanium dioxide (ci 77891) <iln44030>

1 essential oil

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

ORIGINS

VITAZING™
SPF 15

Energy-Boosting
Moisturizer
with Mangosteen
Broad Spectrum
SPF 15

Sheer Tint Release

1.7 fl. oz./oz. liq./50 ml e

INGREDIENTS AND APPEARANCE

VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15 
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0294 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0294 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.02646 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ethyl macadamiate (UNII: ANA2NCS6V1)
butylene glycol (UNII: 3XUS85K0RA)
methyl trimethicone (UNII: S73ZQI0GXM)
hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer (UNII: WB5K9Y35Y9)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
peg-100 stearate (UNII: YD01N1999R)
butyloctyl salicylate (UNII: 2EH13UN8D3)
glyceryl monostearate (UNII: 230OU9XXE4)
agathosma betulina leaf oil (UNII: KOS935A04V)
grapefruit oil (UNII: YR377U58W9)
eucalyptus oil (UNII: 2R04ONI662)
white pine oil (UNII: HA5CX6676U)
bitter almond oil (UNII: 6TQK77W0EX)
mentha arvensis leaf oil (UNII: 1AEY1M553N)
rose oil (UNII: WUB68Y35M7)
asian ginseng (UNII: CUQ3A77YXI)
barley (UNII: 5PWM7YLI7R)
wheat (UNII: 4J2I0SN84Y)
mangifera indica seed butter (UNII: 4OXD9M35X2)
shea butter (UNII: K49155WL9Y)
caffeine (UNII: 3G6A5W338E)
citrus aurantium fruit (UNII: DQD16J2B5O)
chamomile (UNII: FGL3685T2X)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
glycerin (UNII: PDC6A3C0OX)
cetyl alcohol (UNII: 936JST6JCN)
isopropyl myristate (UNII: 0RE8K4LNJS)
trehalose (UNII: B8WCK70T7I)
ethylhexylglycerin (UNII: 147D247K3P)
linoleic acid (UNII: 9KJL21T0QJ)
squalane (UNII: GW89575KF9)
poly(methyl methacrylate; 450000 MW) (UNII: Z47NNT4J11)
dehydroxanthan gum (UNII: 63ZP7I1BQO)
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)
hyaluronate sodium (UNII: YSE9PPT4TH)
caprylyl glycol (UNII: 00YIU5438U)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
citric acid monohydrate (UNII: 2968PHW8QP)
stearic acid (UNII: 4ELV7Z65AP)
silicon dioxide (UNII: ETJ7Z6XBU4)
sodium dehydroacetate (UNII: 8W46YN971G)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
titanium dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-013-01	1 in 1 CARTON	01/01/2017
1		50 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 NOT FINAL	part352	01/01/2017

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(59427-013) , REPACK(59427-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(59427-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-013)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-013)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(59427-013) , REPACK(59427-013)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(59427-013) , REPACK(59427-013)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59427-013)