Label: PLANTSCRIPTION ANTI AGING OIL FREE BROAD SPECTRUM SPF 25- avobenzone, octisalate, and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59427-007-01 - 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 March 25, 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 • ethyl macadamiate • butylene glycol • methyl trimethicone • jojoba esters • lauryl peg-9 polydimethylsiloxyethyl dimethicone • glycerin • peg-100 stearate • glyceryl stearate • anogeissus leiocarpus bark extract • rosa damascena flower oil1, lavandula angustifolia (lavender) oil1, pelargonium graveolens flower oil1, illicium verum (anise) fruit/seed oil1, citrus aurantium bergamia (bergamot) fruit oil1, carthamus tinctorius (safflower) seed oil1, myristica fragrans (nutmeg) kernel oil1, citrus aurantium dulcis (orange) oil1, citrus nobilis (mandarin orange) peel oil1, citrus medica limonum (lemon) peel oil1, litsea cubeba fruit oil1, hibiscus abelmoschus extract, geraniol, linalool, citronellol, limonene • sigesbeckia orientalis (st. paul's wort) extract • polygonum cuspidatum root extract • centaurium erythraea (centaury) extract • rubus idaeus (raspberry) leaf extract • rosmarinus officinalis (rosemary) leaf extract • glycyrrhiza glabra (licorice) leaf extract • poria cocos sclerotium extract • triticum vulgare (wheat) germ extract • hordeum vulgare (barley) extract\extrait d'orge • tetrahexyldecyl ascorbate • sodium hyaluronate • caffeine • salicylic acid • acetyl hexapeptide-8 • silica • potassium cetyl phosphate • butyrospermum parkii (shea butter) • mangifera indica (mango) seed butter • ammonium acryloyldimethyltaurate/vp copolymer • lecithin • linoleic acid • phospholipids • cholesterol • squalane • arginine • cetyl alcohol • ethylhexylglycerin • sodium pca • caprylyl glycol • zinc pca • dehydroxanthan gum • potassium hydroxide • stearic acid • tocopheryl acetate • citric acid • sodium dehydroacetate • phenoxyethanol • mica <iln39390>
- 1
- essential oil
- Other information
- PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
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INGREDIENTS AND APPEARANCE
PLANTSCRIPTION ANTI AGING OIL FREE BROAD SPECTRUM SPF 25
avobenzone, octisalate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.0303 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.0505 g in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.02727 g in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) butyloctyl salicylate (UNII: 2EH13UN8D3) ethyl macadamiate (UNII: ANA2NCS6V1) butylene glycol (UNII: 3XUS85K0RA) methyl trimethicone (UNII: S73ZQI0GXM) lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA) glycerin (UNII: PDC6A3C0OX) peg-100 stearate (UNII: YD01N1999R) glyceryl monostearate (UNII: 230OU9XXE4) anogeissus leiocarpus bark (UNII: U5TP1X38RH) rosa damascena flower oil (UNII: 18920M3T13) lavender oil (UNII: ZBP1YXW0H8) pelargonium graveolens flower oil (UNII: 3K0J1S7QGC) star anise oil (UNII: 6RXP35EIRE) bergamot oil (UNII: 39W1PKE3JI) safflower oil (UNII: 65UEH262IS) nutmeg oil (UNII: Z1CLM48948) orange oil (UNII: AKN3KSD11B) mandarin oil (UNII: NJO720F72R) lemon oil (UNII: I9GRO824LL) litsea oil (UNII: 2XIW34BN6O) geraniol (UNII: L837108USY) linalool, (+/-)- (UNII: D81QY6I88E) .beta.-citronellol, (r)- (UNII: P01OUT964K) polygonum cuspidatum root (UNII: 7TRV45YZF7) centaurium erythraea (UNII: 57X4TSH58S) rubus idaeus leaf (UNII: 8O2V33JG64) rosemary (UNII: IJ67X351P9) glycyrrhiza glabra leaf (UNII: GH32M797Y9) wheat germ (UNII: YR3G369F5A) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) hyaluronate sodium (UNII: YSE9PPT4TH) caffeine (UNII: 3G6A5W338E) salicylic acid (UNII: O414PZ4LPZ) acetyl hexapeptide-8 (UNII: L4EL31FWIL) silicon dioxide (UNII: ETJ7Z6XBU4) potassium cetyl phosphate (UNII: 03KCY6P7UT) shea butter (UNII: K49155WL9Y) mangifera indica seed butter (UNII: 4OXD9M35X2) ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG) linoleic acid (UNII: 9KJL21T0QJ) cholesterol (UNII: 97C5T2UQ7J) squalane (UNII: GW89575KF9) arginine (UNII: 94ZLA3W45F) cetyl alcohol (UNII: 936JST6JCN) ethylhexylglycerin (UNII: 147D247K3P) sodium pyrrolidone carboxylate (UNII: 469OTG57A2) caprylyl glycol (UNII: 00YIU5438U) zinc pidolate (UNII: C32PQ86DH4) potassium hydroxide (UNII: WZH3C48M4T) stearic acid (UNII: 4ELV7Z65AP) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) citric acid monohydrate (UNII: 2968PHW8QP) sodium dehydroacetate (UNII: 8W46YN971G) phenoxyethanol (UNII: HIE492ZZ3T) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59427-007-01 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 11/01/2012 Labeler - ORIGINS NATURAL RESOURCES INC. (611716283) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(59427-007) , REPACK(59427-007) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(59427-007) , RELABEL(59427-007) , REPACK(59427-007) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(59427-007) , RELABEL(59427-007) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(59427-007) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(59427-007) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(59427-007) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(59427-007) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(59427-007) , RELABEL(59427-007) , REPACK(59427-007) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(59427-007) , RELABEL(59427-007) , REPACK(59427-007) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(59427-007) , RELABEL(59427-007) , REPACK(59427-007) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(59427-007) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(59427-007) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 RELABEL(59427-007) , REPACK(59427-007)
