OCEAN POTION SPF30 SUNSCREEN- avobenzone, homosalate, octisalate, 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 30 100ml

OP SPF 30 Lotion

Active Ingredients

Avobenzone 3%, Homosalate 8%, Octisalate 4.5%, Octocrylene 6%

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, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Ascorbic Acid (Vitamin C), C28-52 Olefin/Undecylenic Acid Copolymer, Caprylyl Glycol, Cetearyl Alcohol, Diisopropyl Adipate, Dimethicone, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, Hydrogenated Palm Glycerides, Laminaria Saccharina Extract, Macrocystis Pyrifera Extract, Neopentyl Glycol Diheptanoate, PEG-16 Macadamia, PEG-100 Stearate, Phenethyl Benzoate, Phenoxyethanol, Polyglyceryl-3 Methylglucose Distearate, Potassium Cetyl Phosphate, Pyridoxine HCl (Vitamin B6), Sodium Hydroxide, Tapioca Starch Polymethylsilsesquioxane, Thermus Thermophillus Ferment, Tocopheryl Acetate (Vitamin E), Trisiloxane, Water, Xanthan Gum

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
30
SUNSCREEN LOTION
Scent of sunshine
3.4 FL OZ (100 mL)

PRINCIPAL DISPLAY PANEL
OCEAN 
POTION
SUNCARE
30
SUNSCREEN LOTION
Scent of sunshine
3.4 FL OZ (100 mL)

OCEAN POTION SPF30 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-504
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 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)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
LAMINARIA SACCHARINA EXTRACT (UNII: 68CMP2MB55)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
PEG-16 MACADAMIA GLYCERIDES (UNII: 2OTC93KMHU)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70281-504-24100 mg in 1 BOTTLE; Type 0: Not a Combination Product09/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/15/2017
Labeler - SolSkyn Personal Care LLC (080010329)

Revised: 2/2018
Document Id: 915519e4-c01b-45de-8fb0-16033717e344
Set id: 7ebcc977-c5ae-4720-b201-7d7d32896090
Version: 1
Effective Time: 20180221
 
SolSkyn Personal Care LLC