MAX SHEER ALL DAY MOISTURE DEFENSE (SUNSCREEN LOTION SPF 30) LOTION [PETER THOMAS ROTH LABS LLC]

MAX SHEER ALL DAY MOISTURE DEFENSE (SUNSCREEN LOTION SPF 30) LOTION [PETER THOMAS ROTH LABS LLC]
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NDC 54031-324-00, 54031-324-01, 54031-324-03, 54031-324-04, 54031-324-05, 54031-324-06
Set ID 21a30d5f-7048-48a8-88ed-c529653296c7
Category HUMAN OTC DRUG LABEL
Packager Peter Thomas Roth Labs LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

    Active Ingredients

    Avobenzone 3%
    Homosalate 10%
    Octinoxate 7.5%
    Octisalate 5%
    Octocrylene 2%
    Oxybenzone 6%

  • Purpose

    Sunscreen

    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

    For external use only

  • DO NOT USE

    • Do not use on damaged or broken skin

    When using this product

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    • Stop use and ask a doctor if rash occurs
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
    • If product is swallowed, get medical help or contact a Poison Control Center right away.

  • ​Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if involved in swimming or intense physical activities where sweating will occur
    • reapply at least every 2 hours
    • 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 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-sleeve shirts, pants, hats, and sunglasses 
    • children under 6 months: Ask a doctor
  • ​Inactive Ingredients

    Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Ascorbyl Palmitate, Bentonite, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carbomer, Ceramide 3, Cetyl Alcohol, Dimethicone, Ginkgo Biloba Leaf Extract, Glyceryl Stearate, Panthenol, PEG-100 Stearate, Phenoxyethanol, Phospholipids, Potassium Sorbate, Propylene Glycol, Retinyl Palmitate, Sodium Benzoate, Stearic Acid, Tetrasodium EDTA, Tocopheryl Acetate, Triethanolamine, Water/Aqua/Eau.

  • ​Other Information

    protect this product from excessive heat and direct sun

  • ​Questions or comments?

    Call toll free 1-800-PTR-SKIN (787-7546)

  • ​PRINCIPAL DISPLAY PANEL

    Max Sheer All Day Moisture Defense Carton54031-324-03 BOTTLE - 15ML54031-324-04 BOTTLE - 30ML54031-324-05 BOTTLE - 50ML

  • INGREDIENTS AND APPEARANCE
    MAX SHEER ALL DAY MOISTURE DEFENSE 
    sunscreen lotion spf 30 lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54031-324
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE.001 g  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE.0008 g  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE.0006 g  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE.0005 g  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE.0003 g  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE.0002 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.0048 g  in 1 mL
    Propylene Glycol (UNII: 6DC9Q167V3) 0.0004 g  in 1 mL
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ) 0.0003 g  in 1 mL
    PEG-100 Stearate (UNII: YD01N1999R) 0.00025 g  in 1 mL
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) 0.0003 g  in 1 mL
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 0.0002 g  in 1 mL
    Palmitic Acid (UNII: 2V16EO95H1) 0.0002 g  in 1 mL
    Phenoxyethanol (UNII: HIE492ZZ3T) 0.0001 g  in 1 mL
    Stearic Acid (UNII: 4ELV7Z65AP) 0.0001 g  in 1 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.0001 g  in 1 mL
    Bentonite (UNII: A3N5ZCN45C) 0.000025 g  in 1 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.000025 g  in 1 mL
    Dimethicone (UNII: 92RU3N3Y1O) 0.000025 g  in 1 mL
    Allantoin (UNII: 344S277G0Z) 0.00002 g  in 1 mL
    PEG-8 Dimethicone (UNII: GIA7T764OD) 0.000014 g  in 1 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.00001 g  in 1 mL
    Cetyl Alcohol (UNII: 936JST6JCN) 0.00001 g  in 1 mL
    Panthenol (UNII: WV9CM0O67Z) 0.00001 g  in 1 mL
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) 0.0000087 g  in 1 mL
    EDETATE SODIUM (UNII: MP1J8420LU) 0.0000084 g  in 1 mL
    Myristic Acid (UNII: 0I3V7S25AW) 0.000006 g  in 1 mL
    Potassium Sorbate (UNII: 1VPU26JZZ4) 0.0000025 g  in 1 mL
    Sodium Benzoate (UNII: OJ245FE5EU) 0.0000025 g  in 1 mL
    Arachidic Acid (UNII: PQB8MJD4RB) 0.000002 g  in 1 mL
    Lauric Acid (UNII: 1160N9NU9U) 0.000002 g  in 1 mL
    Ascorbic Acid (UNII: PQ6CK8PD0R) 0.000001 g  in 1 mL
    Octyldodecanol (UNII: 461N1O614Y) 0.000001 g  in 1 mL
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.000001 g  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.000001 g  in 1 mL
    Sodium Propoxyhydroxypropyl Thiosulfate Silica (UNII: 208G222332) 0.000001 g  in 1 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.000001 g  in 1 mL
    Ceramide NP (UNII: 4370DF050B) 0.00000099 g  in 1 mL
    Butylene Glycol (UNII: 3XUS85K0RA) 0.000000395 g  in 1 mL
    GINKGO (UNII: 19FUJ2C58T) 0.0000002 g  in 1 mL
    Butyl Acetate (UNII: 464P5N1905) 0.000000001 g  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54031-324-011 in 1 CARTON07/29/2013
    1NDC:54031-324-001 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:54031-324-0315 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/29/2013
    3NDC:54031-324-0430 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/29/2013
    4NDC:54031-324-061 in 1 CARTON07/29/2013
    4NDC:54031-324-0550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/29/2013
    Labeler - Peter Thomas Roth Labs LLC (780458944)
    Registrant - Peter Thomas Roth Labs LLC (780458944)
    Establishment
    NameAddressID/FEIBusiness Operations
    June Jacobs Labs LLC082439410manufacture(54031-324)

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