Label: CORRECTING CREAM BROAD SPECTRUM SPF 15 ASAP- avobenzone, octinoxate, octocrylene, oxybenzone, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

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 August 4, 2014

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  • ACTIVE INGREDIENT

    Active ingredients          Purpose

    Avobenzone 3%            Sunscreen

    Octinoxate 4%              Sunscreen

    Oxybenzone 3%            Sunscreen

    Zinc Oxide 4.5%            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.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if rash occurs.

    Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out eye. Rinse with water to remove.

    Directions

    Apply 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 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 ingredients: Water (Aqua), Methyl Gluceth-20, Caprylic/Capric Triglyceride, Butylene Glycol, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Triacontanyl PVP, Dimethicone, Citrus Tangerina (Tangerine) Peel Oil, Camellia Sinensis Leaf Extract, Punica Granatum (Pomegranate) Fruit Extract, Phenoxyethanol, Benzyl Alcohol, Triethanolamine, Ethylhexylglycerin, Propylene Glycol, Polysorbate 20, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499).

  • PRINCIPAL DISPLAY PANEL

    asap

    the science of beautiful skin
    correcting cream

    with antixidants

    hydrate + protect
    Broad Spectrum SPF 15 sunscreen
    75 mL/ 2.54 fl oz

    Box image

  • INGREDIENTS AND APPEARANCE
    CORRECTING CREAM BROAD SPECTRUM SPF 15  ASAP
    avobenzone, octinoxate, octocrylene, oxybenzone, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76261-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MANDARIN OIL (UNII: NJO720F72R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76261-126-021 in 1 BOX
    1NDC:76261-126-0175 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/04/2014
    Labeler - AUSTRALIAN SKIN PRODUCTS PTY LTD (752403019)
    Registrant - AUSTRALIAN SKIN PRODUCTS PTY LTD (752403019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Beauty Care Pty Ltd749369716manufacture(76261-126)
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