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

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 Sunstation USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active ingredientS

Octocrylene 8%
Zinc Oxide 8%
Octisalate 5%

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 and as needed.
• 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 increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a 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.

OTHER INFORMATION:

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

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, Sorbitol, Stearic Acid, Symphytum Officinale Extract, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Questions?

(816)686 -1345

Package Labeling:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71272-591
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 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)
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: 71272-591-00	946 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/03/2025

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

Labeler - Sunstation USA LLC (080497172)