Label: DERMA BRILLIANCE SUNSCREEN SPF 30- octinoxate, oxybenzone, octisalate, avobenzone and octocrylene cream

  • 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 March 17, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Octinaxate - 7.5%

    Oxybenzone - 6.0%

    Octisalate - 5.0%

    Avobenzone - 2.0%

    Octocrylene - 1.5%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • This product is suited for broad spectrum UV protection.
  • WARNINGS

    Warnings:

    • For external use only.
  • WHEN USING

    • Keep out of eyes.
    • If, contacts occurs rinse with water.
  • STOP USE

    Discontinue use if irritation or redness occurs.

  • ASK DOCTOR

    Consult a doctor if sever irritation occurs.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply using fingertips 20-30 minutes before exposure to the sun.
    • Gently massage into face and neck.
    • Reapply as needed.
  • INACTIVE INGREDIENT

    Water, Alkyl(C12-15) Benzoate, Butylene Glycol, Octyldodecyl Neopentanoate, Hyaluronate Sodium, Kiwi Fruit, Medium chain Triglycerides, Green Tea Leaf, Teprenone, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Cyclomethicone 5, Cyclomethicone 6, Algae Extract, Artemisia Vulgaris Root, Centella Asiatica, Echinacea Purpurea, Lauryl Methacrylate / Glycol Dimethacrylate, Crosspolymer, Carbomer, Yeast Polysaccharides, Triethanolamine,Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene Glycol 400, Tocopherol, Ascorbyl  Palmitate, Ascorbic Acid, Citric Acid Monohydrate, Sorbitan Mono Oleate, Polysorbate 20, Palmitoyl Pentapeptide-4, Darutoside, Glycerin, Polygonum Aviculare Top, Arctostaphylos UVA-URSI Leaf, Mitracarpus Scaber Extract, Plankton Extract, Egg Phospholipids, Micrococcus Lysate, Arabidopsis Thaliana, Ubidecarenone, Edetate Disodium, Aloe Vera Leaf.

  • PRINCIPAL DISPLAY PANEL

    Distributed by:

    ICTV, 150 Stewart Parkway,

    Greensboro, GA 30642 USA 77 Humberline Drive, Toronto,

    Ont, Canada M9W0B6.

    Image of the Product: Derma Brilliance Sunscreen SPF 30

  • INGREDIENTS AND APPEARANCE
    DERMA BRILLIANCE SUNSCREEN SPF 30 
    octinoxate, oxybenzone, octisalate, avobenzone and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TEPRENONE (UNII: S8S8451A4O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Trolamine (UNII: 9O3K93S3TK)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4073-128.3 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/17/2015
    Labeler - Allure Labs, Inc (926831603)
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