FDA.reportPublic FDA data

Ocean Potion SPF15 Sunscreen

Manufacturer
SolSkyn Personal Care LLC
Effective date
2018-02-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:37

Label at a glance#

ProductOcean Potion SPF15 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure10 sections

Indications and 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

Dosage and administration

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 ...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

OP SPF 15 Lotion

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only
  • Flammable: keep away from fire or flame.

Do not use on damaged or broken skin.

OTC - DO NOT USE SECTION

When using this product keep out of eyes.

OTC - WHEN USING SECTION

Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

OTC - STOP USE SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

MAY STAIN SOME FABRICS, PLASTICS AND WOOD SURFACES.

PRINCIPAL DISPLAY PANEL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70281-506-242020-09-27C16284748780-1ab0e2407-3223-f274-e053-dbdaa90a6471OP SPF 15 200ml
70281-506-242020-09-25C16284748780-1ab0e2407-3223-f274-e053-dbdaa90a6471OP SPF 15 200ml
70281-506-242020-07-22C16284748780-1ab0e2407-3223-f274-e053-dbdaa90a6471OP SPF 15 200ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70281-506-24Ocean Potion SPF15 Sunscreen200 mg in 1 BOTTLELOTION2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70281-506OCEAN POTION SPF15 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [SOLSKYN PERSONAL CARE LLC]1Legacy NDC, 1 package rows20180220_19f27287-7e63-4acd-a68a-6bc49245a5cd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70281-50670281-506-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
SACCHARINA LATISSIMA68CMP2MB55IACT
MACROCYSTIS PYRIFERAK31S3OG5C4IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
PEG-16 MACADAMIA GLYCERIDES2OTC93KMHUIACT
PHENETHYL BENZOATE0C143929GKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
SODIUM HYDROXIDE55X04QC32IIACT
STEARIC ACID4ELV7Z65APIACT
THERMUS THERMOPHILUS LYSATE775R692494IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c1e5bbb2-e1a7-4171-bc5f-0db7ac91f52119f27287-7e63-4acd-a68a-6bc49245a5cd2018-02-21WarningsExact identifier
spl id: c1e5bbb2-e1a7-4171-bc5f-0db7ac91f521
spl set id: 19f27287-7e63-4acd-a68a-6bc49245a5cd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.