EVERY DAY MINERAL SUN SCREEN SPF 45- zinc oxide cream

EVERY DAY MINERAL SUN SCREEN SPF 45 by

Drug Labeling and Warnings

EVERY DAY MINERAL SUN SCREEN SPF 45 by is a Otc medication manufactured, distributed, or labeled by Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

KEEP OUT OF REACH OF CHILDREN

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

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

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

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)

INGREDIENTS AND APPEARANCE

EVERY DAY MINERAL SUN SCREEN SPF 45 
zinc oxide cream

Product 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
18	NDC: 69555-045-18	75 mL in 1 TUBE; Type 0: Not a Combination Product	09/05/2024

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)