Label: RE-NUTRIV ULTIMATE LIFTING MAKEUP SPF15- titanium dioxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 11559-724-01 - Packager: ESTEE LAUDER 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 27, 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
- Purpose
- Use
- Warnings
-
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating
-
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 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
-
Inactive ingredients
water\aqua\eau • cyclopentasiloxane • butylene glycol • phenyl trimethicone • cetyl dimethicone • dimethicone • pentaerythrityl tetraethylhexanoate • octyldodecyl stearoyl stearate • peg/ppg-18/18 dimethicone • cetyl peg/ppg-10/1 dimethicone • magnesium sulfate • ethylhexyl palmitate • astrocaryum murumuru butter • pyrus malus (apple) fruit extract • silybum marianum (lady's thistle) extract • acetyl hexapeptide-8 • oryza sativa (rice) bran extract • pisum sativum (pea) extract • aminopropyl ascorbyl phosphate • tocopheryl acetate • palmitoyl oligopeptide • caffeine • linoleic acid • cholesterol • quaternium-90 bentonite • acetyl carnitine hcl • ascorbyl palmitate • disodium nadh • ethylhexylglycerin • 7-dehydrocholesterol • trimethylsiloxysilicate • tribehenin • phytosteryl/octyldodecyl lauroyl glutamate • methicone • zinc stearate • sorbitan isostearate • laureth-7 • sucrose • trifluoromethyl c1-4 alkyl dimethicone • glyceryl polymethacrylate • hydrolyzed fish (pisces) collagen • propylene carbonate • caprylyl glycol • sodium hyaluronate • peg-8 • hydrogenated lecithin • xanthan gum • alumina • fragrance (parfum) • sodium chloride • bht • chloroxylenol • phenoxyethanol • [+/- iron oxides (ci 77491, ci 77492, ci 77499) • titanium dioxide (ci 77891) • mica] <iln37196>
- Other information
- PRINCIPAL DISPLAY PANEL - 30 ml Container Carton
-
INGREDIENTS AND APPEARANCE
RE-NUTRIV ULTIMATE LIFTING MAKEUP SPF15
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-724 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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) butylene glycol (UNII: 3XUS85K0RA) phenyl trimethicone (UNII: DR0K5NOJ4R) dimethicone (UNII: 92RU3N3Y1O) pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897) octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C) peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794) magnesium sulfate (UNII: DE08037SAB) ethylhexyl palmitate (UNII: 2865993309) astrocaryum murumuru seed butter (UNII: 12V64UPU6R) apple (UNII: B423VGH5S9) milk thistle (UNII: 822I9LEJ7S) acetyl hexapeptide-8 (UNII: L4EL31FWIL) rice bran (UNII: R60QEP13IC) pea (UNII: W4X7H8GYFM) aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) palmitoyl oligopeptide (UNII: HO4ZT5S86C) caffeine (UNII: 3G6A5W338E) linoleic acid (UNII: 9KJL21T0QJ) cholesterol (UNII: 97C5T2UQ7J) acetylcarnitine hydrochloride (UNII: NDW10MX58T) ascorbyl palmitate (UNII: QN83US2B0N) ethylhexylglycerin (UNII: 147D247K3P) 7-dehydrocholesterol (UNII: BK1IU07GKF) tribehenin (UNII: 8OC9U7TQZ0) zinc stearate (UNII: H92E6QA4FV) sorbitan isostearate (UNII: 01S2G2C1E4) laureth-7 (UNII: Z95S6G8201) sucrose (UNII: C151H8M554) propylene carbonate (UNII: 8D08K3S51E) caprylyl glycol (UNII: 00YIU5438U) hyaluronate sodium (UNII: YSE9PPT4TH) polyethylene glycol 400 (UNII: B697894SGQ) hydrogenated soybean lecithin (UNII: H1109Z9J4N) xanthan gum (UNII: TTV12P4NEE) aluminum oxide (UNII: LMI26O6933) sodium chloride (UNII: 451W47IQ8X) butylated hydroxytoluene (UNII: 1P9D0Z171K) chloroxylenol (UNII: 0F32U78V2Q) phenoxyethanol (UNII: HIE492ZZ3T) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-724-01 1 in 1 CARTON 1 30 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2005 Labeler - ESTEE LAUDER INC (005914387) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(11559-724) , REPACK(11559-724) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(11559-724) , RELABEL(11559-724) , REPACK(11559-724) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(11559-724) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(11559-724) , RELABEL(11559-724) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(11559-724) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(11559-724) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(11559-724) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(11559-724) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(11559-724) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(11559-724) , RELABEL(11559-724) , REPACK(11559-724) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(11559-724) , RELABEL(11559-724) , REPACK(11559-724) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(11559-724) , RELABEL(11559-724) , REPACK(11559-724) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(11559-724) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(11559-724) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(11559-724) , RELABEL(11559-724)