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Product NDC Code | 69555-045 | ||||||||||||||||||||||||||||||||||||||
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Drug Name | Every day mineral sun screen spf 45 |
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Type | Brand | ||||||||||||||||||||||||||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||||||||||||||||||||||||||
Dosage Form | CREAM | ||||||||||||||||||||||||||||||||||||||
Application Number | M020 | ||||||||||||||||||||||||||||||||||||||
Labeler Name | Stream2Sea, LLC | ||||||||||||||||||||||||||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredients Zinc Oxide 19% (Non-Nano)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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 Makai Beauty SPF 45 Mineral Sunscreen (75mL) and Counting Coral Everyday Mineral Sunscreen SPF 45 (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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Helps prevent sunburn
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.EVERY DAY MINERAL SUN SCREEN SPF 45 ZINC OXIDE WATER ALOE VERA LEAF COCO-CAPRYLATE ISOAMYL LAURATE GLYCERIN POLYGLYCERYL-3 OLEATE PROPANEDIOL POLYHYDROXYSTEARIC ACID (2300 MW) DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE MICA TRICAPRIN SODIUM CHLORIDE ETHYL LAUROYL ARGINATE HYDROCHLORIDE HYDROLYZED JOJOBA ESTERS (ACID FORM) OLIVE OIL ALARIA ESCULENTA OLEA EUROPAEA LEAF GREEN TEA LEAF HOLY BASIL LEAF COCONUT OIL TURMERIC TETRASODIUM GLUTAMATE DIACETATE TOCOPHEROL SODIUM STEAROYL GLUTAMATE SILICON DIOXIDE XANTHAN GUM FERRIC OXIDE RED ZINC OXIDE ZINC OXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 Counting Coral Everyday Mineral Sunscreen SPF 45 (75mL) EVERY DAY MINERAL SUN SCREEN ACTIVE SPF 45 (75mL) - LABEL NATURAL MINERAL SUNSCREEN EXTREME ELEMENTS SPF 45 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 TINT SPF 45 (75mL) - 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 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 (946mL) - 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 (946mL) - LABEL Label LABEL LABEL Label LABEL
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.If product is swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other info Protect this product from excessive heat & sunlight.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API