OCEAN POTION SPF15 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

Ocean Potion SPF15 Sunscreen by

Drug Labeling and Warnings

Ocean Potion SPF15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by SolSkyn Personal Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

OP SPF 15 Lotion

Active Ingredients

Avobenzone 2%, Homosalate 8%, Octisalate 5%, Octocrylene 5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
  
• 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
  
• Flammable: keep away from fire or flame.

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 occurs.

Keep out of reach of children.

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

Directions

• apply liberally 15 minutes before sun exposure
  
• re-apply:
  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.-2 p.m.
  
• wear long-sleeved shirts, pants, hats and sunglasses
  
• children under 6 months: ask a doctor

Other information

• protect this product from excessive heat and direct sun
  
• For use on skin only. Avoid contact with fabric.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Ascorbic Acid (Vitamin C), C28-52 Olefin/Undecylenic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Diisopropyl Adipate, Dimethicone, Disodium EDTA, Fragrance, Glycerin, Hydrogenated Palm Glycerides, Laminaria Saccharina Extract, Macrocystis Pyrifera Extract, Neopentyl Glycol Diheptanoate, PEG-16 Macadamia, Phenethyl Benzoate, Phenoxyethanol, Polyglyceryl-3 Methylglucose Distearate, Potassium Cetyl Phosphate, Pyridoxine HCl (Vitamin B6), Sodium Hydroxide, Stearic Acid, Tapioca Starch Polymethylsilsesquioxane, Thermus Thermophillus Ferment, Tocopheryl Acetate (Vitamin E), Water

Questions or comments?

www.oceanpotion.com call toll-free 1-800-715-3485

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PRINCIPAL DISPLAY PANEL

OCEAN
POTION
SUNCARE
15
SUNSCREEN LOTION
Scent of sunshine
6.8 FL OZ (200 mL)

INGREDIENTS AND APPEARANCE

OCEAN POTION SPF15 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-506
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mg  in 100 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PEG-16 MACADAMIA GLYCERIDES (UNII: 2OTC93KMHU)
PHENETHYL BENZOATE (UNII: 0C143929GK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-506-24	200 mg in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/15/2015

Labeler - SolSkyn Personal Care LLC (080010329)