Label: PLANTSCRIPTION SPF 15 ANTI-AGING FOUNDATION- octinoxate and titanium dioxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 59427-004-01 - 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 June 4, 2012
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 • cyclopentasiloxane • phenyl trimethicone • peg-10 dimethicone • butylene glycol • dimethicone • isocetyl alcohol • caprylic/capric triglyceride • isododecane • wheat germ glycerides • magnesium sulfate • tribehenin • anogeissus leiocarpus bark extract • rosa damascena flower oil1, lavandula angustifolia (lavender) oil1, pelargonium graveolens flower oil1, illicium verum (anise) 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 • mimosa tenuiflora bark extract • salvia sclarea (clary) extract • scutellaria baicalensis root extract • sigesbeckia orientalis (st. paul's wort) extract • foeniculum vulgare (fennel) seed extract • disteardimonium hectorite • hordeum vulgare (barley) extract\extrait d'orge • triticum vulgare (wheat) germ extract • castanea sativa (chestnut) seed extract • centaurium erythraea (centaury) extract • anthemis nobilis (chamomile) flower extract • simmondsia chinensis (jojoba) seed oil • peg/ppg-18/18 dimethicone • glycerin • squalane • polysilicone-11 • ethylhexyl palmitate • cholesterol • linoleic acid • ethylhexylglycerin • methicone • polymethylsilsesquiane • palmitoyl oligopeptide • caffeine • tocopheryl acetate • sodium hyaluronate • sorbitan sesquioleate • sorbitan stearate • aminopropyl ascorbyl phosphate • trehalose • triethyl citrate • hydrogenated lecithin • propylene carbonate • sorbitan isostearate • laureth-7 • maltodextrin • ascorbyl palmitate • xanthan gum • alumina • chloroxylenol • phenoxyethanol • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499)] <iln38729>
- 1
- essential oil
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
PLANTSCRIPTION SPF 15 ANTI-AGING FOUNDATION
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.4 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) phenyl trimethicone (UNII: DR0K5NOJ4R) butylene glycol (UNII: 3XUS85K0RA) dimethicone (UNII: 92RU3N3Y1O) isocetyl alcohol (UNII: 1800H64066) medium-chain triglycerides (UNII: C9H2L21V7U) isododecane (UNII: A8289P68Y2) wheat germ oil (UNII: 14C97E680P) magnesium sulfate (UNII: DE08037SAB) tribehenin (UNII: 8OC9U7TQZ0) anogeissus leiocarpus bark (UNII: U5TP1X38RH) rosa damascena flower oil (UNII: 18920M3T13) lavender oil (UNII: ZBP1YXW0H8) pelargonium graveolens flower oil (UNII: 3K0J1S7QGC) 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) abelmoschus moschatus seed (UNII: UN2QZ55I88) geraniol (UNII: L837108USY) linalool, (+/-)- (UNII: D81QY6I88E) .beta.-citronellol, (r)- (UNII: P01OUT964K) mimosa tenuiflora bark (UNII: 515MQE449I) scutellaria baicalensis root (UNII: 7J95K7ID2S) fennel seed (UNII: G3QC02NIE6) wheat germ (UNII: YR3G369F5A) spanish chestnut (UNII: 2MT5XMR2YW) centaurium erythraea (UNII: 57X4TSH58S) chamaemelum nobile flower (UNII: O2T154T6OG) jojoba oil (UNII: 724GKU717M) peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794) glycerin (UNII: PDC6A3C0OX) squalane (UNII: GW89575KF9) ethylhexyl palmitate (UNII: 2865993309) cholesterol (UNII: 97C5T2UQ7J) linoleic acid (UNII: 9KJL21T0QJ) ethylhexylglycerin (UNII: 147D247K3P) palmitoyl oligopeptide (UNII: HO4ZT5S86C) caffeine (UNII: 3G6A5W338E) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) hyaluronate sodium (UNII: YSE9PPT4TH) sorbitan sesquioleate (UNII: 0W8RRI5W5A) sorbitan monostearate (UNII: NVZ4I0H58X) aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R) trehalose (UNII: B8WCK70T7I) triethyl citrate (UNII: 8Z96QXD6UM) propylene carbonate (UNII: 8D08K3S51E) sorbitan isostearate (UNII: 01S2G2C1E4) laureth-7 (UNII: Z95S6G8201) maltodextrin (UNII: 7CVR7L4A2D) ascorbyl palmitate (UNII: QN83US2B0N) xanthan gum (UNII: TTV12P4NEE) aluminum oxide (UNII: LMI26O6933) chloroxylenol (UNII: 0F32U78V2Q) phenoxyethanol (UNII: HIE492ZZ3T) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59427-004-01 1 in 1 CARTON 1 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/01/2012 Labeler - ORIGINS NATURAL RESOURCES INC. (611716283) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(59427-004) , REPACK(59427-004) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(59427-004) , RELABEL(59427-004) , REPACK(59427-004) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(59427-004) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(59427-004) , RELABEL(59427-004) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(59427-004) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(59427-004) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(59427-004) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(59427-004) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(59427-004) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(59427-004) , RELABEL(59427-004) , REPACK(59427-004) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(59427-004) , RELABEL(59427-004) , REPACK(59427-004) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(59427-004) , RELABEL(59427-004) , REPACK(59427-004) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(59427-004) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(59427-004) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(59427-004) , RELABEL(59427-004)