![LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONE) LOTION [ARAMIS INC.]](https://medic.hrt.org//dailymed/images/8b206b6d-92e4-48bc-a40c-93ffdd635535/5g8e-01.jpg)
| NDC | 42472-010-01 |
| Set ID | 8b206b6d-92e4-48bc-a40c-93ffdd635535 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | ARAMIS INC. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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\AQUA\EAU ∙ BUTYLOCTYL SALICYLATE ∙ NYLON-12 ∙ OCTYLDODECYL NEOPENTANOATE ∙ BEHENYL ALCOHOL ∙ DIMETHICONE ∙ GLYCERIN ∙ MYRISTYL MYRISTATE ∙ CETYL ESTERS ∙ POLYETHYLENE ∙ BUTYLENE GLYCOL ∙ GLYCERYL STEARATE ∙ PEG-100 STEARATE ∙ PEG-6 ∙ AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER ∙ SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT ∙ THERMUS THERMOPHILLUS FERMENT ∙ SQUALANE ∙ ANASTATICA HIEROCHUNTICA (ROSE OF JERICHO) EXTRACT ∙ TRITICUM VULGARE (WHEAT) GERM EXTRACT ∙ HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE ∙ BETULA ALBA (BIRCH) BARK EXTRACT ∙ LAMINARIA SACCHARINA EXTRACT ∙ SALICORNIA HERBACEA EXTRACT ∙ SACCHAROMYCES LYSATE EXTRACT ∙ ACETYL HEXAPEPTIDE-8 ∙ BIOSACCHARIDE GUM-4 ∙ CAFFEINE ∙ DIPOTASSIUM GLYCYRRHIZATE ∙ CHOLESTEROL ∙ SODIUM PCA ∙ SUCROSE ∙ LINOLEIC ACID ∙ TREHALOSE ∙ ALGAE EXTRACT ∙ TRISILOXANE ∙ SODIUM HYALURONATE ∙ POLYQUATERNIUM-51 ∙ LACTOBACILLUS FERMENT ∙ DI-PPG-2 MYRETH-10 ADIPATE ∙ STEARETH-21 ∙ TOCOPHERYL ACETATE∙ MYRISTYL LAURATE ∙ FRAGRANCE (PARFUM) ∙ CAPRYLYL GLYCOL ∙ MYRISTYL ALCOHOL ∙ UREA ∙ HEXYLENE GLYCOL ∙ SODIUM DEHYDROACETATE ∙ DISODIUM EDTA ∙ BHT ∙ PHENOXYETHANOL <ILN43958>
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
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INGREDIENTS AND APPEARANCE
LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35
avobenzone, homosalate, octisalate, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42472-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.03 g in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.05 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.045 g in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.033 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) NYLON-12 (UNII: 446U8J075B) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) DOCOSANOL (UNII: 9G1OE216XY) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) CETYL ESTERS WAX (UNII: D072FFP9GU) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) THERMUS THERMOPHILUS LYSATE (UNII: 775R692494) SQUALANE (UNII: GW89575KF9) SELAGINELLA LEPIDOPHYLLA (UNII: 02JQ564P1G) WHEAT (UNII: 4J2I0SN84Y) BARLEY (UNII: 5PWM7YLI7R) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) CAFFEINE (UNII: 3G6A5W338E) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) CHOLESTEROL (UNII: 97C5T2UQ7J) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) SUCROSE (UNII: C151H8M554) LINOLEIC ACID (UNII: 9KJL21T0QJ) TREHALOSE (UNII: B8WCK70T7I) TRISILOXANE (UNII: 9G1ZW13R0G) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LACTOBACILLUS REUTERI (UNII: 9913I24QEE) DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ) STEARETH-21 (UNII: 53J3F32P58) MYRISTYL LAURATE (UNII: 58U0NZN2BT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MYRISTYL ALCOHOL (UNII: V42034O9PU) UREA (UNII: 8W8T17847W) HEXYLENE GLYCOL (UNII: KEH0A3F75J) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42472-010-01 1 in 1 CARTON 12/01/2016 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 12/01/2016 Labeler - ARAMIS INC. (042918826) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 RELABEL(42472-010) , REPACK(42472-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(42472-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(42472-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(42472-010) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(42472-010) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 RELABEL(42472-010) , REPACK(42472-010) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 RELABEL(42472-010) , REPACK(42472-010) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(42472-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(42472-010)
