NDC | 49527-731-01 |
Set ID | bc976541-933c-42bb-be62-b09afdabe0cd |
Category | HUMAN OTC DRUG LABEL |
Packager | CLINIQUE LABORATORIES INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- 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 • 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
-
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