Label: DYNAMIC SUNSCREEN BROAD SPECTRUM SPF 55 SUN PROTECTION- octinoxate and zinc oxide cream

  • 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 November 4, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENTS

    Octinoxate 7.5%

    Zinc Oxide 4.8%

  • PURPOSE

    Sunscreen

  • USES

    Help prevent sunburn.

  • 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 doctor if rash or irritation occurs.

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

  • DIRECTIONS

    Apply liberally and evenly 15 minutes before sun exposure. 1Reapply:

    At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 hours.

    • 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 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-sleeve shirts, pants, hats, and sunglasses.

    1
    For children under 6 months of age: Ask a doctor.
  • INACTIVE INGREDIENTS

    Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.

  • OTHER INFORMATION

    Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.

  • River Park Dental Dynamic Sunscreen Broad Spectrum SPF 55 Sun Protection 1.75 fl oz (50ml)

    River Park Dental Dynamic Sunscreen Broad Spectrum SPF 55 Sun Protection 1.75 fl oz (50ml)River Park Dental
    Dynamic Sunscreen Broad Spectrum SPF 55
    Sun Protection
    1.75 fl oz (50ml)

  • INGREDIENTS AND APPEARANCE
    DYNAMIC SUNSCREEN BROAD SPECTRUM SPF 55 SUN PROTECTION 
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82366-5550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE48 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    SORBITOL (UNII: 506T60A25R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALCOHOL (UNII: 3K9958V90M)  
    OCTISALATE (UNII: 4X49Y0596W)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BETULA PUBESCENS BARK (UNII: 3R504894L9)  
    GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
    SAGE (UNII: 065C5D077J)  
    COLA ACUMINATA SEED (UNII: 1F8VIW1479)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ISOMALT (UNII: S870P55O2W)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82366-5550-250 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2021
    Labeler - River Park Dental (080647862)