Label: HAVE A NICE DAY- octinoxate and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59427-783-01 - 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 September 8, 2011
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- Active Ingredients
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Ingredients
water\aqua\eau; mentha piperita (peppermint) leaf water, myrtus communis (myrtle) leaf water • cyclopentasiloxane • butylene glycol • peg-100 stearate • phenyl trim ethicone • myristyl lactate • polysorbate 60 • tocopheryl acetate • dicaprylyl maleate • sorbitan palmitate • potassium stearate • stearyl alcohol • betula alba (white birch) extract • centella asiatica (hydrocotyl) extract • adenosine phosphate • citrus limonum medica (lemon) peel oil1, citrus paradisi (grapefruit) peel oil1, mentha viridis (spearmint) leaf oil1, limonene • phytosqualane • phytosterols • hordeum vulgare (barley) extract\extrait d'orge • glycine soja (soybean) phospholipid • triticum vulgare (wheat) germ extract • squalane • linoleic acid • caffeine • magnesium ascorbyl phosphate • pantethine • tocopherol • glyceryl stearate • ppg-20 methyl glucose ether • aluminum stearate • octyldodecyl neopentanoate • pentylene glycol • glyceryl isostearate • potassium carbomer • bht • disodium edta • sodium dehydroacetate • phenoxyethanol • chlorphenesin <iln33348>
- 1
- essential oil
- PURPOSE
- WARNING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
HAVE A NICE DAY SUPER CHARGED SPF 15
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-783 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 titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP) titanium dioxide 1 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) peppermint oil (UNII: AV092KU4JH) myrtle leaf oil (UNII: 4ZP3Q1OY08) cyclomethicone 5 (UNII: 0THT5PCI0R) butylene glycol (UNII: 3XUS85K0RA) peg-100 stearate (UNII: YD01N1999R) phenyl trimethicone (UNII: DR0K5NOJ4R) myristyl lactate (UNII: 1D822OC34X) polysorbate 60 (UNII: CAL22UVI4M) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) dioctyl maleate (UNII: OD88G8439L) sorbitan monopalmitate (UNII: 77K6Z421KU) potassium stearate (UNII: 17V812XK50) stearyl alcohol (UNII: 2KR89I4H1Y) betula pubescens bark (UNII: 3R504894L9) centella asiatica leaf (UNII: 6810070TYD) adenosine phosphate (UNII: 415SHH325A) lemon oil (UNII: I9GRO824LL) grapefruit oil (UNII: YR377U58W9) spearmint oil (UNII: C3M81465G5) barley (UNII: 5PWM7YLI7R) soybean (UNII: L7HT8F1ZOD) wheat germ (UNII: YR3G369F5A) squalane (UNII: GW89575KF9) linoleic acid (UNII: 9KJL21T0QJ) caffeine (UNII: 3G6A5W338E) magnesium ascorbyl phosphate (UNII: 0R822556M5) pantethine (UNII: 7K81IL792L) tocopherol (UNII: R0ZB2556P8) glyceryl monostearate (UNII: 230OU9XXE4) aluminum stearate (UNII: U6XF9NP8HM) octyldodecyl neopentanoate (UNII: X8725R883T) pentylene glycol (UNII: 50C1307PZG) glyceryl isostearate (UNII: HYE7O27HAO) butylated hydroxytoluene (UNII: 1P9D0Z171K) edetate disodium (UNII: 7FLD91C86K) sodium dehydroacetate (UNII: 8W46YN971G) phenoxyethanol (UNII: HIE492ZZ3T) chlorphenesin (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59427-783-01 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 01/01/2000 Labeler - ORIGINS NATURAL RESOURCES INC. (611716283) Establishment Name Address ID/FEI Business Operations ELGC Kabushiki Kaisha 712808195 RELABEL, REPACK Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE, RELABEL, REPACK Establishment Name Address ID/FEI Business Operations ARAMIS, INC 042918826 MANUFACTURE Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK, RELABEL Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 787336577 MANUFACTURE, RELABEL, REPACK Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 949264774 MANUFACTURE, RELABEL, REPACK Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 618107429 MANUFACTURE, RELABEL, REPACK Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE
