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
  • 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 January 12, 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)

    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 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, Calcium Sodium Borosilicate (and) Iron Oxides C.I.77492
    *ORGANIC INGREDIENTS

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    EVERY DAY MINERAL SUN SCREEN SHIMMER SPF 45 (946mL) - 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/11/2021
    Labeler - Stream2Sea, LLC (052920828)
    Registrant - Stream2Sea, LLC (052920828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stream2Sea, LLC052920828manufacture(69555-045)
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