Label: HYDRATING SPF 50- avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% lotion

  • 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 May 1, 2018

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  • ACTIVE INGREDIENT

    Active ingredients                                                                         Purpose
    Avobenzone 3%............................................................................Sunscreen
    Homosalate 15%..........................................................................Sunscreen
    Octisalate 5%...............................................................................Sunscreen
    Octocrylene 10%..........................................................................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn • higher SPF gives more sunburn
    protection • retains SPF after 80 minutes of activity in the water or
    sweating • provides high protection against sunburn

  • 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

  • DOSAGE & ADMINISTRATION

    Directions • Apply liberally 15 minutes before sun exposure and as
    needed. • Children under 6 months of age: ask a doctor. • Reapply: • after
    80 minutes of swimming or sweating • immediately after towel drying • 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 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. • For sunscreen use: • apply to all skin exposed to the sun.
    • reapply as needed or after towel drying, swimming, or sweating.

  • OTHER SAFETY INFORMATION

    Other information • protect the product in this container from
    excessive heat and direct sun • may stain fabrics

  • INACTIVE INGREDIENT

    Inactive ingredients Aloe Barbadensis Leaf Extract, Aluminum
    Starch Octenylsuccinate, Carbomer, Dimethicone, Disodium EDTA,
    Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Polyglyceryl-3
    Distearate, Retinyl Palmitate, Sorbitan Isostearate, Sorbitol, Stearic Acid,
    Tocopherol, Triethanolamine, VP/Eicosene Copolymer, Water.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDRATING SPF 50 
    avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 g  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polyglyceryl-3 Distearate (UNII: ZI1LK470XV)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    Sorbitol (UNII: 506T60A25R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Tocopherol (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1121-06236 mL in 1 CAN; Type 0: Not a Combination Product11/16/2016
    2NDC:0363-1121-07296 mL in 1 TUBE; Type 0: Not a Combination Product11/16/2016
    3NDC:0363-1121-0389 mL in 1 TUBE; Type 0: Not a Combination Product11/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/16/2016
    Labeler - Walgreens (008965063)
    Registrant - Product Quiest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quiest Mfg927768135manufacture(0363-1121) , label(0363-1121)