OCEAN POTION SPF15 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion 
SolSkyn Personal Care LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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OP SPF 15 200ml

OP SPF 15 Lotion

Active Ingredients

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

Purpose

Sunscreen

Uses

Warnings

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

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:

Other information

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

MAY STAIN SOME FABRICS, PLASTICS AND WOOD SURFACES.

PRINCIPAL DISPLAY PANEL

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

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

OCEAN POTION SPF15 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-506
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 100 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70281-506-24200 mg in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/15/2015
Labeler - SolSkyn Personal Care LLC (080010329)

Revised: 2/2018
Document Id: c1e5bbb2-e1a7-4171-bc5f-0db7ac91f521
Set id: 19f27287-7e63-4acd-a68a-6bc49245a5cd
Version: 1
Effective Time: 20180221
 
SolSkyn Personal Care LLC