NDC | 59427-013-01 |
Set ID | 0fac5204-df18-4774-bb53-115513cb7ff0 |
Category | HUMAN OTC DRUG LABEL |
Packager | ORIGINS NATURAL RESOURCES INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
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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
- PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
-
INGREDIENTS AND APPEARANCE
VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15
avobenzone, octisalate, and octocrylene creamProduct 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) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 MANUFACTURE(59427-013) , REPACK(59427-013) , RELABEL(59427-013) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 REPACK(59427-013) , RELABEL(59427-013) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 MANUFACTURE(59427-013) , REPACK(59427-013) , RELABEL(59427-013) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 MANUFACTURE(59427-013) , REPACK(59427-013) , RELABEL(59427-013) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 MANUFACTURE(59427-013) , REPACK(59427-013) , RELABEL(59427-013) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 REPACK(59427-013) , RELABEL(59427-013) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 REPACK(59427-013) , RELABEL(59427-013) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 RELABEL(59427-013) , REPACK(59427-013) Establishment Name Address ID/FEI Business Operations NORTHTEC PALC 102631997 REPACK(59427-013) , RELABEL(59427-013)