Label: ORIGINS A PERFECT WORLD AGE DEFENSE TINTED MOISTURIZER SPF 15- octinoxate, octisalate, and avobenzone liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 59427-001-01 - 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 February 13, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 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 • dimethicone • caprylic/capric/myristic/stearic triglyceride • butylene glycol • cyclopentasiloxane • steareth-2 • cetyl ricinoleate • di-c12-15 alkyl fumarate • polysilicone-11 • pentylene glycol • steareth-21 • coffea arabica (coffee) seed extract • triticum vulgare (wheat) germ extract • laminaria ochroleuca extract • hordeum vulgare (barley) extract\extrait d'orge • camellia sinensis (white tea) leaf extract • polyethylene • hydrogenated lecithin • stearyl alcohol • polyaminopropyl biguanide • linoleic acid • cholesterol • dimethicone copolyol • squalane • caffeine • sodium pca • urea • caprylic/capric triglyceride • hexylene glycol • sodium hyaluronate • pantethine • polyquaternium-51 • sodium hydroxide • trehalose • oryzanol • ascorbyl tocopheryl maleate • tromethamine • glycerin • peg-9 dimethicone • behenyl alcohol • pvp/hexadecene copolymer • carbomer • caprylyl glycol • fragrance • disodium edta • linalool • limonene • citral • sorbic acid • phenoxyethanol • potassium sorbate • chlorphenesin • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499) • bismuth oxychloride (ci 77163) • ferric ammonium ferrocyanide (ci 77510) • mica • red 7 lake (ci 15850)] <iln38491>
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
ORIGINS A PERFECT WORLD AGE DEFENSE TINTED MOISTURIZER SPF 15
octinoxate, octisalate, and avobenzone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate 7.5 mL in 100 mL octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate 5 mL in 100 mL avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone 2 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) dimethicone (UNII: 92RU3N3Y1O) butylene glycol (UNII: 3XUS85K0RA) cyclomethicone 5 (UNII: 0THT5PCI0R) steareth-2 (UNII: V56DFE46J5) cetyl ricinoleate (UNII: 1P677500YD) di-c12-15 alkyl fumarate (UNII: A1CB3Z898P) pentylene glycol (UNII: 50C1307PZG) steareth-21 (UNII: 53J3F32P58) arabica coffee bean (UNII: 3SW678MX72) wheat germ (UNII: YR3G369F5A) laminaria ochroleuca (UNII: 4R2124HE76) high density polyethylene (UNII: UG00KM4WR7) stearyl alcohol (UNII: 2KR89I4H1Y) polyaminopropyl biguanide (UNII: 322U039GMF) linoleic acid (UNII: 9KJL21T0QJ) cholesterol (UNII: 97C5T2UQ7J) squalane (UNII: GW89575KF9) caffeine (UNII: 3G6A5W338E) sodium pyrrolidone carboxylate (UNII: 469OTG57A2) urea (UNII: 8W8T17847W) medium-chain triglycerides (UNII: C9H2L21V7U) hexylene glycol (UNII: KEH0A3F75J) hyaluronate sodium (UNII: YSE9PPT4TH) pantethine (UNII: 7K81IL792L) sodium hydroxide (UNII: 55X04QC32I) trehalose (UNII: B8WCK70T7I) gamma oryzanol (UNII: SST9XCL51M) tromethamine (UNII: 023C2WHX2V) glycerin (UNII: PDC6A3C0OX) docosanol (UNII: 9G1OE216XY) caprylyl glycol (UNII: 00YIU5438U) edetate disodium (UNII: 7FLD91C86K) linalool, (+/-)- (UNII: D81QY6I88E) citral (UNII: T7EU0O9VPP) sorbic acid (UNII: X045WJ989B) phenoxyethanol (UNII: HIE492ZZ3T) potassium sorbate (UNII: 1VPU26JZZ4) chlorphenesin (UNII: I670DAL4SZ) titanium dioxide (UNII: 15FIX9V2JP) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) bismuth oxychloride (UNII: 4ZR792I587) ferric ammonium ferrocyanide (UNII: 9R0NVI936I) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59427-001-01 1 in 1 CARTON 1 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/01/2011 Labeler - ORIGINS NATURAL RESOURCES INC. (611716283) Establishment Name Address ID/FEI Business Operations ELGC Kabushiki Kaisha 712808195 RELABEL(59427-001) , REPACK(59427-001) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(59427-001) , RELABEL(59427-001) , REPACK(59427-001) Establishment Name Address ID/FEI Business Operations ARAMIS, INC 042918826 MANUFACTURE(59427-001) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(59427-001) , RELABEL(59427-001) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(59427-001) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(59427-001) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(59427-001) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(59427-001) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(59427-001) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 787336577 MANUFACTURE(59427-001) , RELABEL(59427-001) , REPACK(59427-001) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 949264774 MANUFACTURE(59427-001) , RELABEL(59427-001) , REPACK(59427-001) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 618107429 MANUFACTURE(59427-001) , RELABEL(59427-001) , REPACK(59427-001) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(59427-001) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(59427-001)
