Label: YOUTH SURGE SPF 15 AGE DECELERATING MOISTURIZER ANTI RIDES HYDRATANT- octinoxate and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-731-01 - Packager: CLINIQUE LABORATORIES 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 November 18, 2011
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
- Warnings
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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
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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 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
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Inactive ingredients
water • cetyl ethylhexanoate • butylene glycol • octyldodecyl neopentanoate • glyceryl stearate • peg-100 stearate • glycerin • olea europaea (olive) fruit extract • coleus barbatus extract • sigesbeckia orientalis (st. paul's wort) extract • triticum vulgare (wheat bran) extract • polygonum cuspidatum root extract • saccharomyces lysate extract • algae extract • hydrolyzed rice extract • betula alba (birch) bark extract • padina pavonica thallus extract • coffea robusta seed extract • astrocaryum murumuru seed butter • citrus reticulata (tangerine) peel extract • laurdimonium hydroxypropyl hydrolyzed soy protein • hydrogenated lecithin • creatine • ethylhexyl palmitate • polyethylene • pentylene glycol • caffeine • behenyl alcohol • linoleic acid • cetyl alcohol • isoniacinamide • cholesterol • lecithin • sorbitol • trehalose • silica • sodium rna • dipalmitoyl hydroxyproline • disodium nadh • sodium hyaluronate • aminopropyl ascorbyl phosphate • methicone • caprylyl glycol • decarboxy carnosine hcl • potassium sulfate • adenosine phosphate • ethylhexyl stearate • glycine • phytosphingosine • acrylates copolymer • propylene glycol dicaprate • acetyl hexapeptide-8 • hydroxyproline • proline • xanthan gum • alumina • sodium dna • potassium hydroxide • hexylene glycol • carbomer • disodium edta • phenoxyethanol • potassium sorbate [iln36979]
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Carton
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INGREDIENTS AND APPEARANCE
YOUTH SURGE SPF 15 AGE DECELERATING MOISTURIZER ANTI RIDES HYDRATANT
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-731 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 1.4 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERIN (UNII: PDC6A3C0OX) BLACK OLIVE (UNII: 2M6QWV94OC) PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG) WHEAT BRAN (UNII: 6L966A1IMR) POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) BETULA PUBESCENS BARK (UNII: 3R504894L9) PADINA PAVONICA (UNII: 177U06NHZI) ROBUSTA COFFEE BEAN (UNII: V5032728L7) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) TANGERINE PEEL (UNII: JU3D414057) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CREATINE (UNII: MU72812GK0) ETHYLHEXYL PALMITATE (UNII: 2865993309) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PENTYLENE GLYCOL (UNII: 50C1307PZG) CAFFEINE (UNII: 3G6A5W338E) DOCOSANOL (UNII: 9G1OE216XY) LINOLEIC ACID (UNII: 9KJL21T0QJ) CETYL ALCOHOL (UNII: 936JST6JCN) ISONIACINAMIDE (UNII: 4H3BH6YX9Q) CHOLESTEROL (UNII: 97C5T2UQ7J) SORBITOL (UNII: 506T60A25R) PIMAGEDINE HYDROCHLORIDE (UNII: A2Z7G2RGAH) TREHALOSE (UNII: B8WCK70T7I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POTASSIUM SULFATE (UNII: 1K573LC5TV) ADENOSINE PHOSPHATE (UNII: 415SHH325A) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) GLYCINE (UNII: TE7660XO1C) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) HYDROXYPROLINE (UNII: RMB44WO89X) PROLINE (UNII: 9DLQ4CIU6V) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM OXIDE (UNII: LMI26O6933) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-731-01 1 in 1 CARTON 1 50 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 02/24/2009 Labeler - CLINIQUE LABORATORIES INC. (173047747) 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
