OCEAN POTION SUNCARE MINERAL 30 ESSENTIAL SCENT OF SUNSHINE ZINC OXIDE SUNSCREEN- zinc oxide lotion

Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide Sunscreen by

Drug Labeling and Warnings

Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide 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

Zinc Oxide 20.6%

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 skin 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

aloe barbadensis leaf juice, bentonite, bisabolol,
caprylic/capric triglyceride, cetearyl alcohol, dimethicone, ethyl ferulate, farnesol, fragrance,
gluconolactone, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil,
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane,
olive oil polyglyceryl-6 esters, phenoxyethanol, polysorbate 60, polysorbate 80,
sodium benzoate, sodium stearoyl lactylate, sorbitan isostearate, tetrasodium
glutamate diacetate, tocopherol, triethoxycaprylylsilane, VP/hexadecene
copolymer, water, xanthan gum

Label

INGREDIENTS AND APPEARANCE

OCEAN POTION SUNCARE MINERAL 30 ESSENTIAL SCENT OF SUNSHINE ZINC OXIDE SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85638-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	206 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BENTONITE (UNII: A3N5ZCN45C)
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LEVOMENOL (UNII: 24WE03BX2T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
FARNESOL (UNII: EB41QIU6JL)
ISOHEXADECANE (UNII: 918X1OUF1E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ETHYL FERULATE (UNII: 5B8915UELW)
GLUCONOLACTONE (UNII: WQ29KQ9POT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85638-009-66	100 mL in 1 TUBE; Type 0: Not a Combination Product	02/04/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/04/2025

Labeler - GNL BRANDS INTERNATIONAL, LLC (099638248)