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.

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

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

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

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)