SUNSTATION SPORT SUNSCREEN SPF 30- octisalate, octocrylene, zinc oxide cream

Sunstation Sport Sunscreen SPF 30 by

Drug Labeling and Warnings

Sunstation Sport Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Impact Melanoma Inc, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredients

Octisalate 5%
Octocrylene 8%
Zinc Oxide 8%

Purpose

Sunscreen

USES:

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection
• Retains SPF after 80 minutes of swimming or sweating
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS:

For external use only.

Do not use

• on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• Rash or irritation develops and lasts.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

DIRECTIONS:

• Apply liberally 15 minutes before sun exposure & as needed.
• For children under 6 months of age: ask a doctor.
• REAPPLY::
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. -2p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENTS:

Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Calendula Officinalis Extract, Capryloyl Glycerin/Sebacic Acid Copolymer, Carbomer,
Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate
SE, 1,2-Hexanediol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol,
Polyhydroxystearic Acid, Polysorbate 20, Sorbitan Stearate, Sorbitol, Stearic Acid, Symphytum Officinale Extract, Tocopheryl Acetate,
Triethanolamine, Water (Aqua)

OTHER INFORMATION:

• Protect the product in this container from excessive heat and direct sun.

Package Labeling:

INGREDIENTS AND APPEARANCE

SUNSTATION SPORT SUNSCREEN SPF 30 
octisalate, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85528-592
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETEARETH-20 (UNII: YRC528SWUY)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)
ASIAN GINSENG (UNII: CUQ3A77YXI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85528-592-00	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/19/2025

Labeler - Impact Melanoma Inc (009768146)

Registrant - Pure Source, LLC (080354456)