Label: EVERY DAY MINERAL SUN SCREEN SPF 45- zinc oxide cream

  • NDC Code(s): 69555-045-01, 69555-045-02, 69555-045-03, 69555-045-04, view more
    69555-045-05, 69555-045-06, 69555-045-07, 69555-045-08, 69555-045-09, 69555-045-10, 69555-045-11, 69555-045-12, 69555-045-13, 69555-045-14, 69555-045-15
  • Packager: Stream2Sea, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 11, 2023

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  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredients

    Zinc Oxide 19% (Non-Nano)

  • PURPOSE

    Purpose
    Sunscreen

  • INDICATIONS & USAGE

    Uses

    • Helps prevent sunburn
  • WARNINGS

    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.
  • 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.
  • OTHER SAFETY INFORMATION

    Other info

    Protect this product from excessive heat & sunlight.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Every Day Mineral Sun Screen Active SPF 45 (75mL, 50mL and 946mL) & Natural Mineral Sunscreen Extreme Elements SPF 45 (75mL)

    Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum.

    *ORGANIC INGREDIENTS

    Every Day Mineral Sun Screen Tint SPF 45 (75mL, 50mL and 946mL)

    Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum, Iron Oxides, (C.I.77492, C.I.77491, C.I.77499).

    *ORGANIC INGREDIENTS

    Every Day Mineral Sun Screen 4 Kids SPF 45 (75mL, 50mL and 946mL)

    Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum.

    *ORGANIC INGREDIENTS

    Every Day Mineral Sun Screen Shimmer SPF 45 (75mL, 50mL and 946mL)

    Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinensis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum, Calcium Sodium Borosilicate (and) Iron Oxides C.I.77492

    *ORGANIC INGREDIENTS

    Happy Ocean Mineral Sunscreen SPF 45 (75mL) and Happy Ocean Kids Mineral Sunscreen SPF 45 (75mL)

    Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl Lauroyl Arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinensis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum, Calcium Sodium Borosilicate (and) Iron Oxides C.I.77492


    *ORGANIC INGREDIENTS

  • KEEP OUT OF REACH OF CHILDREN

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    EVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (75mL) - LABEL

    EVERY DAY MINERAL SUN SCREEN ACTIVE SPF 45 (75mL) - LABEL

    NATURAL MINERAL SUNSCREEN EXTREME ELEMENTS SPF 45

    NATURAL MINERAL SUNSCREEN EXTREME ELEMENTS SPF 45

    EVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (50mL) - LABEL

    EVERY DAY MINERAL SUN SCREEN ACTIVE SPF 45 (50mL) - LABEL

    EVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (946mL) - LABEL

    EVERY DAY MINERAL SUN SCREEN ACTIVE SPF 45 (946mL) - LABEL

    EVERY DAY MINERAL SUNSCREEN TINT SPF 45 (75mL) - LABEL

    EVERY DAY MINERAL SUN SCREEN TINT SPF 45 (75mL) - LABEL

    EVERY DAY MINERAL SUNSCREEN TINT SPF 45 (50mL) - LABEL

    EVERY DAY MINERAL SUN SCREEN TINT SPF 45 (50mL) - LABEL

    EVERY DAY MINERAL SUNSCREEN TINT SPF 45 (946mL) - LABEL

    EVERY DAY MINERAL SUN SCREEN TINT SPF 45 (946mL) - LABEL

    EVERY DAY MINERAL SUNSCREEN 4 KIDS SPF 45 (75mL) - LABEL

    EVERY DAY MINERAL SUN SCREEN 4 KIDS SPF 45 (75mL) - LABEL

    EVERY DAY MINERAL SUNSCREEN 4 KIDS SPF 45 (50mL) - LABEL

    EVERY DAY MINERAL SUN SCREEN 4 KIDS SPF 45 (50mL) - LABEL

    EVERY DAY MINERAL SUNSCREEN 4 KIDS SPF 45 (946mL) - LABEL

    EVERY DAY MINERAL SUN SCREEN 4 KIDS SPF 45 (946mL) - LABEL

    EVERY DAY MINERAL SUNSCREEN SHIMMER SPF 45 (75mL) - LABEL

    EVERY DAY MINERAL SUN SCREEN SHIMMER SPF 45 (75mL) - LABEL

    EVERY DAY MINERAL SUNSCREEN SHIMMER SPF 45 (50mL) - LABEL

    EVERY DAY MINERAL SUN SCREEN SHIMMER SPF 45 (50mL) - LABEL

    EVERY DAY MINERAL SUNSCREEN SHIMMER SPF 45 (946mL) - LABEL

    EVERY DAY MINERAL SUN SCREEN SHIMMER SPF 45 (946mL) - LABEL

    HAPPY OCEAN MINERAL SUNSCREEN SPF 45 (75mL) - LABEL

    Label

    HAPPY OCEAN KIDS MINERAL SUNSCREEN SPF 45 (75mL) - LABEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    EVERY DAY MINERAL SUN SCREEN SPF 45 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69555-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE190 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)  
    MICA (UNII: V8A1AW0880)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HOLY BASIL LEAF (UNII: SCJ765569P)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TURMERIC (UNII: 856YO1Z64F)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69555-045-0175 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2021
    2NDC:69555-045-0250 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2021
    3NDC:69555-045-03946 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2021
    4NDC:69555-045-0475 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2021
    5NDC:69555-045-0550 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2021
    6NDC:69555-045-06946 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2021
    7NDC:69555-045-0775 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2021
    8NDC:69555-045-0850 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2021
    9NDC:69555-045-09946 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2021
    10NDC:69555-045-1075 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2021
    11NDC:69555-045-1150 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2021
    12NDC:69555-045-12946 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2021
    13NDC:69555-045-1375 mL in 1 TUBE; Type 0: Not a Combination Product06/03/2023
    14NDC:69555-045-1475 mL in 1 TUBE; Type 0: Not a Combination Product12/11/2023
    15NDC:69555-045-1575 mL in 1 TUBE; Type 0: Not a Combination Product12/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/11/2021
    Labeler - Stream2Sea, LLC (052920828)
    Registrant - Stream2Sea, LLC (052920828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stream2Sea, LLC052920828manufacture(69555-045)
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