Label: EVERY DAY MINERAL SUN SCREEN SPF 45- zinc oxide cream
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NDC Code(s):
69555-045-01,
69555-045-02,
69555-045-03,
69555-045-04, view more69555-045-05, 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, 69555-045-16, 69555-045-17
- Packager: Stream2Sea, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 14, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- Directions
- OTHER SAFETY INFORMATION
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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 INGREDIENTSEvery 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 INGREDIENTSEvery 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 INGREDIENTSEvery 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 INGREDIENTSHappy 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 INGREDIENTSMakai Beauty SPF 45 Mineral Sunscreen (75mL)
Aloe Barbadensis Leaf Juice*, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Curcuma Longa (Turmeric) Root* Extract, Deionized Water, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethyl Lauroyl Arginate HCl, Hibiscus Sabdariffa Flower Extract, Chamomilla Recutita (Chamomile) Extract, Camellia Sinensis Leaf (White Tea) Extract, Alaria Esculenta (Wakame Seaweed) Extract, Camellia Sinensis (Green Tea) Leaf Extract*, Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Olea Europaea (Olive) Leaf Extract* in Cocos Nucifera (Coconut) Oil, Isoamyl Laurate, Jojoba Esters, Mica, Mixed Tocopherols, Olive Squalane Oil, Polyglyceryl-3 Oleate, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Chloride, Sodium Stearoyl glutamate, Tetrasodium Glutamate Diacetate, Vegetarian Glycerin, Xanthan Gum
*ORGANIC INGREDIENTS
Makai CC Cream
Deionized Water, Aqueous Extracts (Chamomile, Green Tea Leaf*, Hibiscus, Olive Leaf*, Tulsi Leaf*, Wakame Seaweed*), Caprylic/Capric Triglyceride, Aloe Leaf Juice, Cocoglycerides, Glycerin, Cetearyl Alcohol, Cetyl Palmitate, Polyhdroxystearic Acid, Sorbitan Olivate, Cetearyl Olivate, Methylcellulose, Olive Squalane Oil, Coconut Oil*, Stearic Acid, Acrylates Copolymer, Magnesium Aluminum Silicate, Sorbitan Palmitate, Tocopherol, Xanthan Gum, Alumina, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Iron Oxides (CI 77492, CI 77491, CI 77499), Jojoba Esters
*ORGANIC INGREDIENTS
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
EVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (75mL) - LABEL
NATURAL MINERAL SUNSCREEN EXTREME ELEMENTS SPF 45
EVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (50mL) - LABEL
EVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (946mL) - LABEL
EVERY DAY MINERAL SUNSCREEN TINT SPF 45 (75mL) - LABEL
EVERY DAY MINERAL SUNSCREEN TINT SPF 45 (50mL) - LABEL
EVERY DAY MINERAL SUNSCREEN TINT SPF 45 (946mL) - LABEL
EVERY DAY MINERAL SUNSCREEN 4 KIDS SPF 45 (75mL) - LABEL
EVERY DAY MINERAL SUNSCREEN 4 KIDS SPF 45 (50mL) - LABEL
EVERY DAY MINERAL SUNSCREEN 4 KIDS SPF 45 (946mL) - LABEL
EVERY DAY MINERAL SUNSCREEN SHIMMER SPF 45 (75mL) - LABEL
EVERY DAY MINERAL SUNSCREEN SHIMMER SPF 45 (50mL) - LABEL
EVERY DAY MINERAL SUNSCREEN SHIMMER SPF 45 (946mL) - LABEL
HAPPY OCEAN MINERAL SUNSCREEN SPF 45 (75mL) - LABEL
HAPPY OCEAN KIDS MINERAL SUNSCREEN SPF 45 (75mL) - LABEL
MAKAI BEAUTY SPF 45 MINERAL SUNSCREEN, 75 ML - LABEL
Makai Beauty CC Cream SPF 45, 30mL - Label
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INGREDIENTS AND APPEARANCE
EVERY DAY MINERAL SUN SCREEN SPF 45
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69555-045 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 190 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69555-045-01 75 mL in 1 TUBE; Type 0: Not a Combination Product 11/11/2021 2 NDC:69555-045-02 50 mL in 1 TUBE; Type 0: Not a Combination Product 11/11/2021 3 NDC:69555-045-03 946 mL in 1 TUBE; Type 0: Not a Combination Product 11/11/2021 4 NDC:69555-045-04 75 mL in 1 TUBE; Type 0: Not a Combination Product 11/11/2021 5 NDC:69555-045-05 50 mL in 1 TUBE; Type 0: Not a Combination Product 11/11/2021 6 NDC:69555-045-06 946 mL in 1 TUBE; Type 0: Not a Combination Product 11/11/2021 7 NDC:69555-045-07 75 mL in 1 TUBE; Type 0: Not a Combination Product 11/11/2021 8 NDC:69555-045-08 50 mL in 1 TUBE; Type 0: Not a Combination Product 11/11/2021 9 NDC:69555-045-09 946 mL in 1 TUBE; Type 0: Not a Combination Product 11/11/2021 10 NDC:69555-045-10 75 mL in 1 TUBE; Type 0: Not a Combination Product 11/11/2021 11 NDC:69555-045-11 50 mL in 1 TUBE; Type 0: Not a Combination Product 11/11/2021 12 NDC:69555-045-12 946 mL in 1 TUBE; Type 0: Not a Combination Product 11/11/2021 13 NDC:69555-045-13 75 mL in 1 TUBE; Type 0: Not a Combination Product 06/03/2023 14 NDC:69555-045-14 75 mL in 1 TUBE; Type 0: Not a Combination Product 12/11/2023 15 NDC:69555-045-15 75 mL in 1 TUBE; Type 0: Not a Combination Product 12/11/2023 16 NDC:69555-045-16 75 mL in 1 TUBE; Type 0: Not a Combination Product 06/03/2024 17 NDC:69555-045-17 30 mL in 1 TUBE; Type 0: Not a Combination Product 06/03/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/11/2021 Labeler - Stream2Sea, LLC (052920828) Registrant - Stream2Sea, LLC (052920828) Establishment Name Address ID/FEI Business Operations Stream2Sea, LLC 052920828 manufacture(69555-045)