Label: SPF 30 FACE MOISTURIZER- avobenzone, homosalate, octinoxate, octisalate, 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 26, 2021

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  • ACTIVE INGREDIENT

    Active Ingredient        Purpose

    Avobenzone 3%        sunscreen

    Homosalate 10%      sunscreen

    Octinoxate 7.5%       sunscreen

    Octisalate 2.75%      sunscreen

    Oxybenzone 5%       sunscreen

  • PURPOSE

    Uses

    • Helps prevent sunburn
    • If used as directed with other sun proctection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
    • Retains SPF up to 80 minutes of activity in the water
  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if:  Rash or irritation develops and lasts.

  • 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

    • Apply liberally and evenly to dry skin 15 minutes before sun exposure and as often as needed.
    • Re-apply at least every 2 hours; after 80 minutes of  swimming or perspiring; immediately after towel drying.
    • Children under 6 months of age, consult your physician
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regualarly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    •   Limit time in the sun from 10am-2pm
    • wear long sleeve shirts, pants, hats and sunglasses
  • INACTIVE INGREDIENT

    Water(Aqua), Butyloctyl Salicylate, Dimethicone, Corn Start Modified, Hexylene Glycol, VP/Eicosene Copolymer, Glcyerin, Cetearyl Alcohol, PEG-12 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Panthenol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Butyrospermum Parkii (shea) Oil, Epilobium Angustifolium Flower/leaf/stem extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sorbitan Stearate, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Calcium Pantothenate, Sodium Hydroxide, Chlorphenesin, Disodium EDTA, Potassium Sorbate, PEG-40 Stearate, Phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    (Malin + Goetz)

    SPF 30 Face Moisturizer

    Broad Spectrum SPF 30 All skin types

    Water Resistant

    1.7 fl. oz. 50 ml

    carton

    tube

  • INGREDIENTS AND APPEARANCE
    SPF 30 FACE MOISTURIZER 
    avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53634-255
    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) HOMOSALATE10 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.75   in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5   in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE FEROX LEAF (UNII: 0D145J8EME)  
    SHEANUT OIL (UNII: O88E196QRF)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53634-255-021 in 1 CARTON12/05/2017
    1NDC:53634-255-0150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/05/2017
    Labeler - Malin and Goetz Inc (138615930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Milbar Laboratories,Inc.195556790manufacture(53634-255)
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