FDA.reportPublic FDA data

Ocean Potion Face with Clear Zinc Oxide Broad Spectrum SPF 50 Sunscreen

Manufacturer
GNL BRANDS INTERNATIONAL, LLC
Effective date
2025-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:36

Label at a glance#

ProductOcean Potion Face with Clear Zinc Oxide Broad Spectrum SPF 50 Sunscreen
Active ingredientZINC OXIDE, OCTOCRYLENE
Label structure12 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 aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure. reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: Ask a doctor 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 a Broad Spectrum SPF value of 15 or higher and other sun p...

Storage and handling

protect the product in this container from excessive heat and direct sun may stain or damage some fabrics, materials or surfaces

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 4.0%, Zinc Oxide 5.0%

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 aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

​• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure.
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • 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 a Broad Spectrum SPF value 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

Other information

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, ethylhexyl stearate, diisopropyl adipate, cetyl dimethicone, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, phenoxyethanol, beeswax, isohexadecane, hydrogenated castor oil, fragrance, silica, triethoxycaprylylsilane, dimethicone, tocopherol (Vitamin E), tetrasodium EDTA, aloe barbadensis leaf juice, sodium chloride, sodium ascorbyl phosphate.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OP86077TEOP86077TE

OP86077EOP86077E

OP86077KOP86077K

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85638-006-42Ocean Potion Face with Clear Zinc Oxide Broad Spectrum SPF 50 Sunscreen30 mL in 1 JARLOTION301

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85638-00685638-006-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
SODIUM CHLORIDE451W47IQ8XIACT
EDETATE SODIUMMP1J8420LUIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HEXYL LAURATE4CG9F9W01QIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
ALOE VERA LEAFZY81Z83H0XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
YELLOW WAX2ZA36H0S2VIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
ISOHEXADECANE918X1OUF1EIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIMETHICONE92RU3N3Y1OIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
Ocean Potion Face with Clear Zinc Oxide Broad Spectrum SPF 50 SunscreenOCTOCRYLENE, ZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3c6f3e0b-2dff-6dc3-e063-6394a90abb0e2025-08-15WarningsExact identifier
ndc (package): 85638-006-42
ndc (product): 85638-006
ndc11 (package): 85638000642
spl id: 3c6f3e1d-9cae-8fcf-e063-6394a90a8d60
spl set id: 3c6f3e0b-2dff-6dc3-e063-6394a90abb0e

Reported adverse events (FAERS/openFDA)#

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