OCEAN POTION FACE WITH CLEAR ZINC OXIDE BROAD SPECTRUM SPF 50 SUNSCREEN- octocrylene, zinc oxide lotion

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

Drug Labeling and Warnings

Ocean Potion Face with Clear Zinc Oxide Broad Spectrum SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by GNL BRANDS INTERNATIONAL, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octocrylene 4.0%, Zinc Oxide 5.0%

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 aging caused by the sun

Warnings

For external use only

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

Directions

• 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

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

Inactive ingredients

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

INGREDIENTS AND APPEARANCE

OCEAN POTION FACE WITH CLEAR ZINC OXIDE BROAD SPECTRUM SPF 50 SUNSCREEN 
octocrylene, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85638-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50.2125 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
YELLOW WAX (UNII: 2ZA36H0S2V)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ISOHEXADECANE (UNII: 918X1OUF1E)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85638-006-42	30 mL in 1 JAR; Type 0: Not a Combination Product	12/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/17/2024

Labeler - GNL BRANDS INTERNATIONAL, LLC (099638248)