MedPath

EVERY DAY MINERAL SUN SCREEN SPF 45

EVERY DAY MINERAL SUN SCREEN SPF 45

Approved
Approval ID

7ec4954f-7d60-405b-8bff-cb602fc44a4e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 4, 2025

Manufacturers
FDA

Stream2Sea, LLC

DUNS: 052920828

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69555-045
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 4, 2025
FDA Product Classification

INGREDIENTS (28)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
COCO-CAPRYLATEInactive
Code: 4828G836N6
Classification: IACT
ISOAMYL LAURATEInactive
Code: M1SLX00M3M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYGLYCERYL-3 OLEATEInactive
Code: XRQ165498B
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATEInactive
Code: G3232Z5S2O
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
TRICAPRINInactive
Code: O1PB8EU98M
Classification: IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)Inactive
Code: UDR641JW8W
Classification: IACT
OLIVE OILInactive
Code: 6UYK2W1W1E
Classification: IACT
ALARIA ESCULENTAInactive
Code: EJ9JK8J58D
Classification: IACT
OLEA EUROPAEA LEAFInactive
Code: MJ95C3OH47
Classification: IACT
GREEN TEA LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
HOLY BASIL LEAFInactive
Code: SCJ765569P
Classification: IACT
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
TURMERICInactive
Code: 856YO1Z64F
Classification: IACT
TETRASODIUM GLUTAMATE DIACETATEInactive
Code: 5EHL50I4MY
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ZINC OXIDEActive
Quantity: 190 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ETHYL LAUROYL ARGINATE HYDROCHLORIDEInactive
Code: XPD6ZY79TB
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
SODIUM STEAROYL GLUTAMATEInactive
Code: 65A9F4P024
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/14/2024

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelEVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (75mL) - LABEL

![EVERY DAY MINERAL SUN SCREEN ACTIVE SPF 45 (75mL) - LABEL](/dailymed/image.cfm?name=everyday-mineral-sunscreen- active-75ml.jpg&id=874682)

NATURAL MINERAL SUNSCREEN EXTREME ELEMENTS SPF 45

![NATURAL MINERAL SUNSCREEN EXTREME ELEMENTS SPF 45](/dailymed/image.cfm?name=natural-mineral-sunscreen-extreme-elements- spf-45.jpg&id=874682)

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

![EVERY DAY MINERAL SUN SCREEN ACTIVE SPF 45 (50mL) - LABEL](/dailymed/image.cfm?name=everyday-mineral-sunscreen- active-50ml.jpg&id=874682)

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

![EVERY DAY MINERAL SUN SCREEN ACTIVE SPF 45 (946mL) - LABEL](/dailymed/image.cfm?name=everyday-mineral-sunscreen- active-946ml.jpg&id=874682)

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

![EVERY DAY MINERAL SUN SCREEN TINT SPF 45 (75mL) - LABEL](/dailymed/image.cfm?name=everyday-mineral-sunscreen- tint-75ml.jpg&id=874682)

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

![EVERY DAY MINERAL SUN SCREEN TINT SPF 45 (50mL) - LABEL](/dailymed/image.cfm?name=everyday-mineral-sunscreen- tint-50ml.jpg&id=874682)

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

![EVERY DAY MINERAL SUN SCREEN TINT SPF 45 (946mL) - LABEL](/dailymed/image.cfm?name=everyday-mineral-sunscreen- tint-946ml.jpg&id=874682)

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

![EVERY DAY MINERAL SUN SCREEN 4 KIDS SPF 45 (75mL) - LABEL](/dailymed/image.cfm?name=everyday-mineral-sunscreen- kids-75ml.jpg&id=874682)

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

![EVERY DAY MINERAL SUN SCREEN 4 KIDS SPF 45 (50mL) - LABEL](/dailymed/image.cfm?name=everyday-mineral-sunscreen- kids-50ml.jpg&id=874682)

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

![EVERY DAY MINERAL SUN SCREEN 4 KIDS SPF 45 (946mL) - LABEL](/dailymed/image.cfm?name=everyday-mineral-sunscreen- kids-946ml.jpg&id=874682)

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

![EVERY DAY MINERAL SUN SCREEN SHIMMER SPF 45 (75mL) - LABEL](/dailymed/image.cfm?name=everyday-mineral-sunscreen- shimmer-75ml.jpg&id=874682)

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

![EVERY DAY MINERAL SUN SCREEN SHIMMER SPF 45 (50mL) - LABEL](/dailymed/image.cfm?name=everyday-mineral-sunscreen- shimmer-50ml.jpg&id=874682)

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

![EVERY DAY MINERAL SUN SCREEN SHIMMER SPF 45 (946mL) - LABEL](/dailymed/image.cfm?name=everyday-mineral-sunscreen- shimmer-946ml.jpg&id=874682)

HAPPY OCEAN MINERAL SUNSCREEN SPF 45 (75mL) - LABEL

Label

HAPPY OCEAN KIDS MINERAL SUNSCREEN SPF 45 (75mL) - LABEL

LABEL

MAKAI BEAUTY SPF 45 MINERAL SUNSCREEN, 75 ML - LABEL

LABEL

Makai Beauty CC Cream SPF 45, 30mL - Label

Label

Counting Coral Everyday Mineral Sunscreen SPF 45 (75mL)

![LABEL](/dailymed/image.cfm?name=Counting- Coral_SPF45-75ml%284.5x4.5%29+%281%29.jpg&id=874682)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/11/2021

Uses

  • Helps prevent sunburn

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/11/2021

Drug Facts

Active ingredients

Zinc Oxide 19% (Non-Nano)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/11/2021

Purpose
Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 11/11/2021

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/11/2023

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/11/2021

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

LOINC: 60561-8Updated: 11/11/2021

Other info

Protect this product from excessive heat & sunlight.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/5/2024

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

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EVERY DAY MINERAL SUN SCREEN SPF 45 - FDA Drug Approval Details