Label: BRIGHTER BY NATURE SPF 35 SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM- homosalate, octisalate, avobenzone, and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59427-008-01 - Packager: ORIGINS NATURAL RESOURCES INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 10, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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Inactive ingredients
water\aqua\eau • butyloctyl salicylate • methyl trimethicone • jojoba esters • polyester-8 • ethyl macadamiate • butylene glycol • lauryl peg-9 polydimethylsiloxyethyl dimethicone • peg-100 stearate • butyrospermum parkii (shea butter) • glyceryl stearate • citrus aurantifolia (lime) oil1, citrus grandis (grapefruit) peel oil1, cymbopogon schoenanthus oil1, mentha viridis (spearmint) leaf oil1, salvia sclarea (clary) oil1, ormenis multicaulis oil1, pelargonium graveolens flower oil1, lavandula angustifolia (lavender) oil1, thymus vulgaris (thyme) oil1, coriandrum sativum (coriander) fruit oil1, citral, geraniol, linalool, citronellol, limonene • gentiana lutea (gentian) root extract • hordeum vulgare (barley) extract\extrait d'orge • paeonia albiflora (peony) root extract • sanguisorba officinalis (burnet) root extract • cucumis sativus (cucumber) fruit extract • perilla ocymoides leaf extract • pyrus malus (apple) fruit extract • hydrolyzed rice bran extract • scutellaria baicalensis root extract • triticum vulgare (wheat) germ extract • polygonum tinctorium leaf/stem extract • curcuma longa (turmeric) root extract • palmaria palmata extract • trametes versicolor extract • micrococcus lysate • mangifera indica (mango) seed butter • silica • potassium cetyl phosphate • cetyl alcohol • ethylhexylglycerin • arginine • ascorbyl glucoside • caffeine • lecithin • phytosterols • salicylic acid • cholesterol • behenyl alcohol • tocotrienols • linoleic acid • sodium hyaluronate • squalane • magnesium ascorbyl phosphate • elaeis guineensis (palm) oil • squalene • phospholipids • ammonium acryloyldimethyltaurate/vp copolymer • caprylyl glycol • tocopheryl acetate • glycyrrhetinic acid • dehydroxanthan gum • sodium hydroxide • tocopherol • stearic acid • sodium dehydroacetate • phenoxyethanol • mica <iln38194>
- 1
- essential oil
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
BRIGHTER BY NATURE SPF 35 SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM
homosalate, octisalate, avobenzone, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.0498 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.0498 g in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.02988 g in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.02689 g in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) butyloctyl salicylate (UNII: 2EH13UN8D3) methyl trimethicone (UNII: S73ZQI0GXM) ethyl macadamiate (UNII: ANA2NCS6V1) butylene glycol (UNII: 3XUS85K0RA) lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA) peg-100 stearate (UNII: YD01N1999R) shea butter (UNII: K49155WL9Y) glyceryl monostearate (UNII: 230OU9XXE4) lime oil (UNII: UZH29XGA8G) citrus maxima fruit rind oil (UNII: 8U3877WD44) cymbopogon schoenanthus oil (UNII: XE7K568ILO) spearmint oil (UNII: C3M81465G5) clary sage oil (UNII: 87L0D4U3M0) pelargonium graveolens flower oil (UNII: 3K0J1S7QGC) lavender oil (UNII: ZBP1YXW0H8) thyme oil (UNII: 2UK410MY6B) coriander oil (UNII: 7626GC95E5) citral (UNII: T7EU0O9VPP) geraniol (UNII: L837108USY) linalool, (+/-)- (UNII: D81QY6I88E) .beta.-citronellol, (r)- (UNII: P01OUT964K) gentiana lutea root (UNII: S72O3284MS) paeonia lactiflora root (UNII: 3Z3866YW6P) sanguisorba officinalis root (UNII: 4NYV2HT01X) cucumber (UNII: YY7C30VXJT) perilla frutescens top (UNII: T4L5881Y68) apple (UNII: B423VGH5S9) scutellaria baicalensis root (UNII: 7J95K7ID2S) wheat germ (UNII: YR3G369F5A) persicaria tinctoria top (UNII: 4D6LH3E17E) turmeric (UNII: 856YO1Z64F) dulse (UNII: 7832HOY4ZQ) mangifera indica seed butter (UNII: 4OXD9M35X2) silicon dioxide (UNII: ETJ7Z6XBU4) potassium cetyl phosphate (UNII: 03KCY6P7UT) cetyl alcohol (UNII: 936JST6JCN) ethylhexylglycerin (UNII: 147D247K3P) arginine (UNII: 94ZLA3W45F) ascorbyl glucoside (UNII: 2V52R0NHXW) caffeine (UNII: 3G6A5W338E) salicylic acid (UNII: O414PZ4LPZ) cholesterol (UNII: 97C5T2UQ7J) docosanol (UNII: 9G1OE216XY) tocotrienols (UNII: KP2MW85SSQ) linoleic acid (UNII: 9KJL21T0QJ) hyaluronate sodium (UNII: YSE9PPT4TH) squalane (UNII: GW89575KF9) magnesium ascorbyl phosphate (UNII: 0R822556M5) palm oil (UNII: 5QUO05548Z) squalene (UNII: 7QWM220FJH) ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG) caprylyl glycol (UNII: 00YIU5438U) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) enoxolone (UNII: P540XA09DR) sodium hydroxide (UNII: 55X04QC32I) tocopherol (UNII: R0ZB2556P8) stearic acid (UNII: 4ELV7Z65AP) sodium dehydroacetate (UNII: 8W46YN971G) phenoxyethanol (UNII: HIE492ZZ3T) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59427-008-01 1 in 1 CARTON 1 50 mL in 1 JAR 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 ELGC K.K. 712808195 RELABEL(59427-008) , REPACK(59427-008) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(59427-008) , RELABEL(59427-008) , REPACK(59427-008) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(59427-008) , RELABEL(59427-008) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(59427-008) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(59427-008) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(59427-008) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(59427-008) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(59427-008) , RELABEL(59427-008) , REPACK(59427-008) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(59427-008) , RELABEL(59427-008) , REPACK(59427-008) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(59427-008) , RELABEL(59427-008) , REPACK(59427-008) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(59427-008) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(59427-008) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(59427-008) , RELABEL(59427-008)
