ETHOSUN SHIMMER DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 45- zinc oxide cream ETHOSUN DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 45- zinc oxide cream

EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45 by

Drug Labeling and Warnings

EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45 by is a Otc medication manufactured, distributed, or labeled by EthoSun, Inc, Stream2Sea. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Do not Use

On damaged or broken skin.

Stop use and ask doctor 

if rash occurs.

Directions

• Apply liberally 15 mins before aun exposure.
• Reapply after 80 mins of swimming or sweating or immediately after towel drying and at least evary 2 hrs.
• For children under 6 months of age; ask doctor.

Other Info

Protect product from excessive heat and sun.

Purpose:

Sunscreen

Keep out of reach of children.

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

Uses:

Helps prevent sunburn.

Directions:

- Apply liberally 15 minutes before sun exposure.
- Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- For children under 6 months of age: ask a doctor.

Inactive Ingredients:

Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Glycerin*, Butyloctyl Salicylate, Isopropyl Lauroyl Sarcosinate, Lauryl Glucoside, Polyglyceryl-3 Caprate, Polyhydroxystearic Acid, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Magnesium Sulfate, Cetearyl Alcohol, Polyglyceryl-10 Oleate, Polyhydroxystearic Acid, Stearalkonium Hectorite, Sodium Chloride, Tocopherol (Vitamin E), Helianthus Annuus (Sunflower) Seed Oil*, Opuntia Ficus-Indica (Prickly Pear) Extract*, Macrocystis Pyrifera (Kelp) Extract*, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis (Green Tea) Extract*, Euterpe Oleracea (Acai) Fruit Extract*, Cucurbita Pepo (Pumpkin) Seed Extract*, Sodium Dehydroacetate, Ethylhexylglycerin, Sodium Gluconate, Citric Acid, Sodium Citrate, Potassium Sorbate, Sodium Benzoate, Fragrance**, Iron Oxide (CI 77491), Mica, Titanium Dioxide

*Organic Ingredients

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.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ETHOSUN SHIMMER DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 45 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85233-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.19 g  in 1 [arb'U]

Inactive Ingredients
Ingredient Name	Strength
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CURCUMA LONGA (TURMERIC) ROOT (UNII: 856YO1Z64F)
WATER (UNII: 059QF0KO0R)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)
OPUNTIA FICUS-INDICA SEED OIL (UNII: 1XGW49AK2J)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SQUALENE (UNII: 7QWM220FJH)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
PROPANEDIOL (UNII: 5965N8W85T)
SILICA (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85233-0003-2	1 in 1 PACKAGE	04/30/2025
1		1 [arb'U] in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/30/2025

ETHOSUN DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 45 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85233-0000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.19 g  in 1 [arb'U]

Inactive Ingredients
Ingredient Name	Strength
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CURCUMA LONGA (TURMERIC) ROOT (UNII: 856YO1Z64F)
WATER (UNII: 059QF0KO0R)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)
OPUNTIA FICUS-INDICA SEED OIL (UNII: 1XGW49AK2J)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SQUALENE (UNII: 7QWM220FJH)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
PROPANEDIOL (UNII: 5965N8W85T)
SILICA (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85233-0000-2	1 in 1 TUBE	04/30/2025
1		1 [arb'U] in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	part352	04/30/2025

Labeler - EthoSun, Inc (135390665)

Registrant - EthoSun, Inc (135390665)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea		052920828	manufacture(85233-0003, 85233-0000)