Label: CONCEPT II SOLSCENTS BROAD SPECTRUM SPF 30 ANGELICA- avobenzone, homosalate, octisalate, octocrylene and oxybenzone 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 January 17, 2020

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  • Active Ingredients

    Avobenzone 3% Homosalate 7.5%

    Octisalate 5% Octocrylene 2.75% Oxybenzone 2%

  • 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. If product is swallowed, get medical help or contact a Poison COntrol Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • 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 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 INGREDIENT

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

  • Other Information

    • protect this product from excesive heat and direct sun
  • Questions or comments?

    SolScents, LLC. 2200 N.W. 92nd Avenue. Miami, Florida 33172

  • Concept II SolScents Broad Spectrum SPF 30 Angelica

    Principal Display Image

  • INGREDIENTS AND APPEARANCE
    CONCEPT II  SOLSCENTS BROAD SPECTRUM SPF 30 ANGELICA
    avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20.2 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.3 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE75.75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50.5 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0212-4236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/23/2013
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0212) , manufacture(58443-0212) , label(58443-0212)
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