Label: DAILY MOISTURIZER BROAD-SPECTRUM SPF 30- avobenzone, octinoxate, octisalate lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 27, 2014

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  • Active Ingredients

    Avobenzone 3.00%

    Octinoxate 7.50%

    Octisalate 5.0%

  • Use

    Helps prevent sunburn. If used as directed with other sun protection measures, helps decrease the risk of skin cancer and early signs of 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 docor if rash occurs
    • Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use water resistant sunscreen if swimming or sweathing
    • Reapply at least every 2 hours
    • Children under 6 months: ask a doctor
    • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
  • Inactive Ingredients

    Water (Aqua, Eau), Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Butylene Glycol, Mica, Titanium Dioxide (CI 77891), Glycerin, Simmondsia Chinensis Seed Oil, Butyrospermum Parkii (Shea) Butter, Hexapeptide-33, Stearic Acid, Behenyl Alcohol, Glyceryl Stearate, Lecithin,Myristyl Alcohol, Lauryl Alcohol, Cetyl Alcohol, Palmitic Acid, Cetearyl Alcohol, Coco-Glucoside, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Prunus Armeniaca Kernel Oil, Carica Papaya Fruit Extract, Cymbopogon Schoenanthus Extract, Aesculus Hippocastanum Seed Extract, Aloe Barbadensis Leaf Extract, Polysorbate 20, Sorbitan Laurate, Propylene Glycol Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Sodium Hydroxide, Propylene Glycol Laurate, Ethylhexylglycerin, Disodium Edta, Phenoxyethanol, o-Cymen-5-Ol, Fragrance (Parfum), Benzyl Alcohol, Benzyl Salicylate, Butylphenyl Methylpropional, d-Limonene

  • Other Information

    Protect this product form excessive heat and direct sun

  • Principal Display Panel

    59735-130-01

  • INGREDIENTS AND APPEARANCE
    DAILY MOISTURIZER BROAD-SPECTRUM SPF 30 
    avobenzone, octinoxate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BEHENYL BENZOATE (UNII: DQG8119XKJ)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    PRUNUS ARMENIACA LEAF (UNII: 0X5YG5R83N)  
    CARICA PAPAYA LEAF (UNII: 66J7636Z2I)  
    CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
    AESCULUS HIPPOCASTANUM LEAF (UNII: Z49U891FNQ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    SODIUM HYDRIDE (UNII: 23J3BHR95O)  
    PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    LIMONENE, DL- (UNII: 9MC3I34447)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59735-130-0150 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/27/2014
    Labeler - Mana Products (078870292)
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