Label: BEACH BREAK 2-IN-1 DAILY FACIAL MOISTURIZER SUNSCREEN SPF 30- homosalate, octisalate, avobenzone, octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 25, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Homosalate 8% Sunscreen

    Octisalate 5%

    Avobenzone 3%

    Octocrylene 2%

  • PURPOSE

    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
    • Higher SPF gives more sunburn protection
    • Retains SPF after 40 minutes activity in the water, sweating, or perspiring
    • Provides high protection against sunburn
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    Warnings

    • For external use only
    • Do not use on broken or damaged skin
    • When using this product keep out of eyes
    • If product is swallowed, get medical help or contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION

    Directions

    Apply liberally 15 minutes before sun exposure and at least every 2 hours

    Reapply:

    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • 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 Broad Spectrum SPF of 15 or higher and other sun protection measures including:

    • Limit time in the sun, especially from 10 a.m. to 2 p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water (Aqua), Diisopropyl Adidpate, Dicaprylyl Ether, Pentylene Glycol, Stearyl/octyldodecyl Citrate Crosspolymer, Glycerin, Cetyl Alcohol, Potassium Cetyl Phosphate, Phenoxyethanol, Glyceryl Caprylate, Sodium Polyacrylate, Cetearyl Olivate, Sorbitan Olivate, Ferulic Acid, Tetrahexyldecyl Ascorbate, Caprylic/Capric Triglyceride, Limonene, Caprylhydroxamic Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Ethylhexylglycerin, Niacinamide, Sodium Gluconate, Aminomethyl Propanol, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Jasminum Officinale (Jasmine) Extract, Linalool, Tocopherol, Eugenia Caryophyllus (Clove) Flower Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/ Stem Extract, Vitis Vinifera (Grape) Fruit Extract, Glycine Soja (Soybean) Oil

  • PRINCIPAL DISPLAY PANEL

    Vertra

    30

    Beach Break Daily Facial Moisturizer

    Broad Spectrum SPF 30

    Water Resistant (40 minutes)

    1.6 FL OZ / 45.36 mL

    Beach break outer

  • INGREDIENTS AND APPEARANCE
    BEACH BREAK 2-IN-1 DAILY FACIAL MOISTURIZER SUNSCREEN SPF 30 
    homosalate, octisalate, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71014-038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    FERULIC ACID (UNII: AVM951ZWST)  
    LINALOOL, (-)- (UNII: 3U21E3V8I2)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    WINE GRAPE (UNII: 3GOV20705G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71014-038-0145.36 mL in 1 BOTTLE; Type 0: Not a Combination Product09/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02009/21/2022
    Labeler - EAI-JR 286 (827896718)
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