NDC | 42472-887-01 |
Set ID | af05f2b7-bd7f-42a0-8042-92a0e07f0c36 |
Category | HUMAN OTC DRUG LABEL |
Packager | ARAMIS INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
- 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
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Inactive Ingredients
WATER\AQUA\EAU • BUTYLENE GLYCOL • SILICA • HYDROGENATED POLYISOBUTENE • NEOPENTYL GLYCOL DIETHYLHEXANOATE • CYCLOPENTASILOXANE • PENTYLENE GLYCOL • HYDROGENATED LECITHIN • ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE • SACCHAROMYCES LYSATE EXTRACT • ACETYL CARNITINE HCL • BETULA ALBA (BIRCH) BARK EXTRACT • PHYTOSPHINGOSINE • CREATINE • OCTYLDODECYL NEOPENTANOATE • COFFEA ROBUSTA SEED EXTRACT • ASTROCARYUM MURUMURU SEED BUTTER • ASCORBYL TOCOPHERYL MALEATE • ACETYL GLUCOSAMINE • LINOLEIC ACID • SODIUM HYALURONATE • TOCOPHERYL ACETATE • CETEARYL ALCOHOL • POLYPHOSPHORYLCHOLINE GLYCOL ACRYLATE • ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER • PHOSPHOLIPIDS • ETHYLHEXYLGLYCERIN • ISOHEXADECANE • CHOLESTEROL • NEOPENTYL GLYCOL DIISOSTEARATE • ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER • CAPRYLIC/CAPRIC TRIGLYCERIDE • GLYCERIN • LECITHIN • BEHENYL ALCOHOL • ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT • CHAMOMILLA RECUTITA (MATRICARIA) • ETHYLHEXYL STEARATE • CARBOMER • ETHYLHEXYL PALMITATE • PROPYLENE GLYCOL DICAPRATE • CYCLODEXTRIN • NORDIHYDROGUAIARETIC ACID • SODIUM DNA • LINOLENIC ACID • TRIETHANOLAMINE • SODIUM HYDROXIDE • POLYSORBATE 80 • HEXYLENE GLYCOL • DISODIUM EDTA • POTASSIUM SORBATE • SODIUM DEHYDROACETATE • CHLORPHENESIN • PHENOXYETHANOL • SORBIC ACID <ILN37073>
- Other information
- PRINCIPAL DISPLAY PANEL - 100 ml Tube Carton
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INGREDIENTS AND APPEARANCE
LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15
avobenzone, octinoxate, and octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42472-887 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.0212 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0795 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.0318 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PENTYLENE GLYCOL (UNII: 50C1307PZG) ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) ACETYLCARNITINE HYDROCHLORIDE (UNII: NDW10MX58T) BETULA PUBESCENS BARK (UNII: 3R504894L9) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) CREATINE (UNII: MU72812GK0) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) ROBUSTA COFFEE BEAN (UNII: V5032728L7) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5) N-ACETYLGLUCOSAMINE (UNII: V956696549) LINOLEIC ACID (UNII: 9KJL21T0QJ) HYALURONATE SODIUM (UNII: YSE9PPT4TH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ISOHEXADECANE (UNII: 918X1OUF1E) CHOLESTEROL (UNII: 97C5T2UQ7J) NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW) GLYCERIN (UNII: PDC6A3C0OX) DOCOSANOL (UNII: 9G1OE216XY) ROSEMARY (UNII: IJ67X351P9) MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ETHYLHEXYL PALMITATE (UNII: 2865993309) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) MASOPROCOL (UNII: 7BO8G1BYQU) LINOLENIC ACID (UNII: 0RBV727H71) TROLAMINE (UNII: 9O3K93S3TK) SODIUM HYDROXIDE (UNII: 55X04QC32I) POLYSORBATE 80 (UNII: 6OZP39ZG8H) HEXYLENE GLYCOL (UNII: KEH0A3F75J) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42472-887-01 1 in 1 CARTON 01/01/2005 1 100 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2005 Labeler - ARAMIS INC. (042918826) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 RELABEL(42472-887) , REPACK(42472-887) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(42472-887) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(42472-887) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(42472-887) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(42472-887) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 RELABEL(42472-887) , REPACK(42472-887) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 RELABEL(42472-887) , REPACK(42472-887) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(42472-887) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(42472-887)