GUARD SUNSCREEN BROAD SPECTRUM SPF 30 (OCTINOXATE, AVOBENZONE) LOTION [COSMETIC ENTERPRISES LTD]

GUARD SUNSCREEN BROAD SPECTRUM SPF 30 (OCTINOXATE, AVOBENZONE) LOTION [COSMETIC ENTERPRISES LTD]
PDF | XML

NDC 56152-5008-1
Set ID 7d7d17a0-7607-1d70-e053-2a91aa0a564f
Category HUMAN OTC DRUG LABEL
Packager COSMETIC ENTERPRISES LTD
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Ethylhexylmethoxycinnamate (Octinoxate) 2.0% Sunscreen

    ButylMethoxydibenzoylmethane (avobenzone) .5% Sunscreen

  • PURPOSE

    Uses

    Helps Prevent 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.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    For Sunscreen use:

    • Aply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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
    • Children under 6 months of age: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Carthamus Tinctorius (Safflower) Oleosomes, C12-15 Alkyl Benzoate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Phospholipids, Retinyl Palmitate (Vitamin A), Ascorbyl Palmitate (Vitamin C), Tocopheryl Nicotinate, Beta Glucan, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Disodium EDTA, Vanilla Planifola Fruit Extract

  • PRINCIPAL DISPLAY PANEL

    Guard Sunscreen

    High Definition Protection

    Ecran Solaire Total

    Haute Definition

    SPF 30

    Broad Spectrum UVA/UVB

    Anti-age

    1.5fl oz/ 44ml

    carton

  • INGREDIENTS AND APPEARANCE
    GUARD SUNSCREEN BROAD SPECTRUM SPF 30 
    octinoxate, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-5008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)  
    VANILLA (UNII: Q74T35078H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56152-5008-144 mL in 1 CARTON; Type 0: Not a Combination Product12/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/20/2018
    Labeler - COSMETIC ENTERPRISES LTD (017701475)
    Registrant - COSMETIC ENTERPRISES LTD (017701475)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMETIC ENTERPRISES LTD017701475manufacture(56152-5008)

Related Drugs