VITAZING ENERGY BOOSTING MOISTURIZER SPF 15- avobenzone, octisalate, octocrylene cream

VITAZING by

Drug Labeling and Warnings

VITAZING by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

active ingredients: avobenzone 3.00% [] octisalate 3.00% [] octocrylene 2.70%

INACTIVE INGREDIENT

inactive ingredients: water\aqua\eau; citrus aurantium amara (bitter orange) flower water, anthemis nobilis (chamomile) flower extract [] 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 oil*, citrus paradisi (grapefruit) peel oil*, eucalyptus globulus (eucalyptus) leaf oil*, abies sibirica (pine) oil*, prunus amygdalus amara (bitter almond) kernel oil*, mentha arvensis (field mint) leaf oil*, rosa damascena (rose) oil*, 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 [] cholesterol [] potassium cetyl phosphate [] glyceryl polymethacrylate [] cetyl alcohol [] isopropyl myristate [] trehalose [] ethylhexylglycerin [] linoleic acid [] squalane [] polymethyl methacrylate [] dehydroxanthan gum [] ascorbyl tocopheryl maleate [] 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)

WARNINGS

warning: keep out of eyes. stop use if irritation occurs. keep out of reach of children.

PRINCIPAL DISPLAY PANEL

principal display panel:

origins

Vitazing SPF 15

Energy Boosting Moisturizer

with Mangosteen

1.7 fl oz./oz liq/50 ml

origins natural resources inc

new york, ny 10022

INGREDIENTS AND APPEARANCE

VITAZING  ENERGY BOOSTING MOISTURIZER SPF 15
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.0 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-705-01	1 in 1 CARTON
1	NDC: 59427-705-02	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2010

Labeler - ORIGINS NATURAL RESOURCES INC (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		205952385	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aramis Inc.		042918826	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Bristol		949264774	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		618107429	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd		253616536	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Distribution Center		208579636	repack, relabel

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Kabushiki Kaisha		712808195	relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Whitman Laboratories Ltd.		216866277	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	manufacture