ETHOSUN ETHOSPORT STICK BROAD SPECTRUM SPF 40- zinc oxide cream

EthoSun EthoSport Stick Broad Spectrum SPF 40 by

Drug Labeling and Warnings

EthoSun EthoSport Stick Broad Spectrum SPF 40 by is a Otc medication manufactured, distributed, or labeled by EthoSun, Inc, Stream2Sea, LLC. 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.

Other Info

Protect product from excessive heat and sun.

PURPOSE

Purpose:
Sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients:
Candelilla Wax, Cera Alba (Beeswax), Extracts of Laminaria Saccharina (Sugar Kelp) in Coconut Oil and Opuntia Ficus-Indica (Prickly Pear Cactus) Seed, Jojoba Esters, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalane (Plant-Based)

*CERTIFIED ORGANIC INGREDIENTS

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.

INDICATIONS & USAGE

Uses:
Helps prevent sunburn

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ETHOSUN ETHOSPORT STICK BROAD SPECTRUM SPF 40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85233-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.2 g  in 1 [arb'U]

Inactive Ingredients
Ingredient Name	Strength
BEESWAX (UNII: 2ZA36H0S2V)
SILICA (UNII: ETJ7Z6XBU4)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL (UNII: 66YXD4DKO9)
HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
SQUALENE (UNII: 7QWM220FJH)
PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
CANDELILLA WAX (UNII: WL0328HX19)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85233-1000-5	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	M020	04/30/2025

Labeler - EthoSun, Inc (135390665)

Registrant - EthoSun, Inc (135390665)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea, LLC		052920828	manufacture(85233-1000)