DAILY DEFENSE ANTIOXIDANT DAY BROAD SPECTRUM SPF 30 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [SKIN ACTIVES SCIENTIFIC, LLC]

DAILY DEFENSE ANTIOXIDANT DAY BROAD SPECTRUM SPF 30 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [SKIN ACTIVES SCIENTIFIC, LLC]
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NDC 70249-707-01
Set ID 41a0afe9-4c05-4f23-8893-07e374bc40f6
Category HUMAN OTC DRUG LABEL
Packager Skin Actives Scientific, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • DRUG FACTS:

  • Active Ingredients:

    Octinoxate  7.5%

    Octisalate  4.0%

    Zinc Oxide  2.5%

    Sunburn Protection

  • Uses:

    • Helps prevent sunburn.
    • If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Directions:

    • Apply liberally 15-minutes before sun exposure.
    • Reapply:

          -At least every two hours.

          -Immediately after swimming, sweating or towel drying.

    SUN PROTECTION MEASURES: Spending time in the increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

          -Limit time in the sun, especially between 10am and 2pm.

          -Wear long sleeve shirts, pants, hats and sunglasses.

          -For children under 6-months, consult a physician.

  • 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 consult physician

    if irritation or rash developes.

    Keep out of reach of children.

    If product is swallowed, get medical attention or contact poison control center immediately.

  • Inactive Ingredients:

    Aloe barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Astaxanthin, C13-14 Isoparaffin, Camellia sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Ferulic Acid, Glutaredoxin (sH-Polypeptide-77), Glycerin, Glyceryl Stearate SE, Sodium Hyaluronate, Lactobacillus/Kelp Ferment Filterate, Laureth-7, Lycopene, Cholesteryl Oleyl Carbonate (and) Cholesteryl Nonanoate (and) Cholesteryl Chloride (and) BHT, Mangiferin, Phenoxyethanol, polyacrylamide, Polysorbate-20, Prunus amygdalus dulcis (Sweet Almond) Oil, Punica granatum (Pomegranate) Extract, Sesamum indicum (Sesame) Seed Oil, Sodium PCA, Sorbitan Olivate, Squalane, Stearyl Alcohol, Superoxide Dismutase, Thioredoxin (sH-Polypeptide-2), Tocopherol, Tocotrienols, Lutein, Zemea Propanediol, Thioctic Acid, β-Carotene 

  • Package Labeling:

    label1

  • INGREDIENTS AND APPEARANCE
    DAILY DEFENSE ANTIOXIDANT DAY BROAD SPECTRUM SPF 30 
    octinoxate, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70249-707
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERULIC ACID (UNII: AVM951ZWST)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LYCOPENE (UNII: SB0N2N0WV6)  
    CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE)  
    CHOLESTERYL NONANOATE (UNII: 4313O7P4XW)  
    CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MANGIFERIN (UNII: 1M84LD0UMD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    SESAME OIL (UNII: QX10HYY4QV)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SQUALANE (UNII: GW89575KF9)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    THIOREDOXIN (UNII: XJZ418133Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TOCOTRIENOLS (UNII: KP2MW85SSQ)  
    LUTEIN (UNII: X72A60C9MT)  
    THIOCTIC ACID (UNII: 73Y7P0K73Y)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70249-707-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product02/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/11/2015
    Labeler - Skin Actives Scientific, LLC (033957260)

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