Label: LIGHT HEARTED BROAD SPECTRUM SPF 30 SUNSCREEN- octisalate, octocrylene, zinc oxide lotion

  • NDC Code(s): 73001-005-45
  • Packager: Sunday Riley Modern Skincare, LLC
  • 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 23, 2021

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  • Active Ingredients

    Octisalate 5%
    Octocrylene 3.5%
    Zinc Oxide 16.32% 

  • 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 on damaged or broken skin

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

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children

  • Directions

    • Apply generously 15 minutes before sun exposure
    • Children under 6 months of age: Ask a doctor
    • Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases 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
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating

  • Inactive Ingredients

    Water/Eau/Aqua, Octyldodecanol, Dimethicone, Alcohol Denat., Polypropylsilsesquioxane, C12-C15 Alkyl Benzoate , Cyclopentasiloxane, Polyhydroxystearic Acid, Cetyl Diglyceryl Tris (Trimethylsiloxy) silylethyl Dimethicone, Isododecane, PPG-24-Glycereth-24, Curcuma Longa (Turmeric) Root Extract, Xanthophyll, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Corallina Officinalis Extract, Betaine, Coccinia Indica Fruit extract, Dimethicone/Vinyl Dimethicone Crosspolymer, Octyldodecyl Xyloside, PEG-30 Dipolyhydroxystearate, Magnesium stearate, Triethoxycaprylysilane, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Dimethicone Crosspolymer, Carthamus Tinctorius (Saffflower) seed oil, Methylpropanediol, Caprylyl Glycol, Polyquaternium-80, Didecyldimonium Chloride, Magnesium Sulphate, Sodium Chloride, Magnesium Myristate

  • Other Information

    Protect the product in this container from excessive heat and direct sun

  • SPL UNCLASSIFIED SECTION

    Distributed By

    Sunday Riley Modern Skincare, LLC
    Houston, Texas (TX) 77027, USA

  • PACKAGE LABEL

    image description

  • INGREDIENTS AND APPEARANCE
    LIGHT HEARTED BROAD SPECTRUM SPF 30 SUNSCREEN 
    octisalate, octocrylene, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73001-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene3.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION16.32 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ISODODECANE (UNII: A8289P68Y2)  
    PPG-24-GLYCERETH-24 (UNII: V341SPY84U)  
    TURMERIC (UNII: 856YO1Z64F)  
    LUTEIN (UNII: X72A60C9MT)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    BETAINE (UNII: 3SCV180C9W)  
    COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)  
    PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73001-005-451 in 1 BOX04/16/2021
    145 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/16/2021
    Labeler - Sunday Riley Modern Skincare, LLC (012302640)
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