Label: 4OCEAN REEF SAFE SUNSCREEN SPF 40- zinc oxide cream
SPORT SUNSCREEN SPF40- zinc oxide cream
SOGGY DOLLAR ZINC SUN SCREEN SPF 40- zinc oxide cream

  • NDC Code(s): 69555-040-01, 69555-041-01, 69555-042-01
  • Packager: Stream2Sea, LLC
  • 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 April 5, 2023

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  • DRUG FACTS

    Products Name

    Active Ingredients

    4OCEAN REEF SAFE SUNSCREEN SPF 40

    20% Zinc Oxide (Non-Nano)

    SPORT SUNSCREEN SPF 40

    20% Zinc Oxide(Non-Nano EcoSafe Zinc ™)

    SOGGY DOLLAR ZINC SUNSCREEN SPF 40

    20% Zinc Oxide (Non-Nano EcoSafe TM Zinc)

  • Purpose

    • Sunscreen
  • Uses

    • Helps prevent sunburn
  • Warnings

    • For external use only.
    • Do not use on damaged or broken skin.
    • Stop use and ask a doctor if rash occurs.
    • When using this product, keep out of eyes, rinse with water to remove.
    • Keep babies and young children out of direct sunlight. 
  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
    • For children under 6 months of age; ask a doctor.
    • Wear UPF clothing and apply to exposed skin in small amounts to start.
  • Inactive Ingredients

    4OCEAN REEF SAFE SUNSCREEN SPF 40

    • Prunus Amygdalus Dulcis (Sweet Almond) Oil, Helianthus Annuus (Sunflower) Seed Oil, Cera Alba (Beeswax), Jojoba Esters, Sorbitan Olivate, Polyhydroxystearic Acid, Squalane (Plant-Based), Silica, Mixed Tocopherols (Vitamin E).

    SPORT SUNSCREEN SPF 40

    • Prunus Amygdalus Dulcis (Sweet Almond) Oil, Extracts of Camellia Sinensis (Green Tea) Leaf *, Ocimum Tenuiflorum (Tulsi)Leaf *, Alaria Esculenta (Wakame Seaweed) * and Olea Europaea (Olive) Leaf * in Helianthus Annuus (Sunflower) Seed Oil, Cera Alba (Beeswax), Jojoba Esters, Sorbitan Olivate, Polyhydroxystearic Acid, Squalane (Plant-Based), Silica, Mixed Tocopherols (Vitamin E) *CERTIFIED ORGANIC INGREDIENTS.

    SOGGY DOLLAR ZINC SUNSCREEN SPF 40

    • Sweet Almond Oil, Extracts of Chamomile* and Calendula* in Sunflower Seed Oil, Beeswax, Jojoba Esters, Sorbitan Olivate, Polyhydroxystearic Acid, Squalane (Plant-Based), Silica, Fragrance (Naturally-Derived), Vitamin E *CERTIFIED ORGANIC INGREDIENTS.

    Other Information for SOGGY DOLLAR ZINC SUNSCREEN SPF 40

    The most renowned oceanfront bar Soggy Dollar has joined forces with the most rigorously tested suncare brand Stream2Sea to safeguard both your skin and our environment. This ecoconscious collaboration has created a safe sunscreen for you, your family and the planet.

    Manufactured in the USA by: Stream2Sea, LLC

    Bowling Green, FL 33834 

    Questions: 866-960-9513 

    Stream2Sea.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    4Ocean Reef Safe Sunscreen SPF 40 - Jar Label 

    image description

    Sport Sunscreen SPF 40 Jar Label

    sport-sunscreen-spf-40-labels

    Soggy Dollar Sinc Sunscreen SPF 40 Jar Label

    soggydollar-spf-40-labels

  • INGREDIENTS AND APPEARANCE
    4OCEAN REEF SAFE SUNSCREEN SPF 40 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69555-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.2 g  in 80 g
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SQUALANE (UNII: GW89575KF9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69555-040-0180 g in 1 JAR; Type 0: Not a Combination Product03/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/27/2023
    SPORT SUNSCREEN SPF40 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69555-041
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.2 g  in 80 g
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HOLY BASIL LEAF (UNII: SCJ765569P)  
    ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SQUALANE (UNII: GW89575KF9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69555-041-0180 g in 1 JAR; Type 0: Not a Combination Product03/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/27/2023
    SOGGY DOLLAR ZINC SUN SCREEN SPF 40 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69555-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.2 g  in 80 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SQUALENE (UNII: 7QWM220FJH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69555-042-0180 g in 1 JAR; Type 0: Not a Combination Product03/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/27/2023
    Labeler - Stream2Sea, LLC (052920828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stream2Sea, LLC052920828manufacture(69555-040, 69555-041, 69555-042)
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