OCEAN POTION SUNCARE MINERAL 50 ZINC OXIDE CONTINUOUS SUNSCREEN- zinc oxide spray

Ocean Potion Suncare Mineral 50 Zinc Oxide Continuous Sunscreen by

Drug Labeling and Warnings

Ocean Potion Suncare Mineral 50 Zinc Oxide Continuous 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

FLAMMABLE:

do not use near heat, flame or while smoking

avoid long term storage above 104°F (40°C)

​Do not use

• ​​on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

keep away from to avoid breathing it.

do not puncture or incinerate. Contents under pressure.

do not store at temperatures above 120° F.

Stop use and ask 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

spray liberally and spread evenly by hand 15 minutes before sun exposure
hold can 4-6 inches away from skin top apply
do not spray into face. Spray into hand and apply to face.
use in a well ventilated areas

reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours

children under 6 months: 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 the container from excessive heat and direct sun
may stain or damage some fabrics

Inactive ingredients

aloe barbadensis leaf juice, bisabolol,
C12-C15 alkyl benzoate, caprylic/capric triglyceride, cetearyl alcohol,
dimethicone, ethyl ferulate, farnesol, 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

Labels

INGREDIENTS AND APPEARANCE

OCEAN POTION SUNCARE MINERAL 50 ZINC OXIDE CONTINUOUS SUNSCREEN 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85638-000
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 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
LEVOMENOL (UNII: 24WE03BX2T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
FARNESOL (UNII: EB41QIU6JL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ETHYL FERULATE (UNII: 5B8915UELW)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85638-000-37	156 g in 1 CAN; Type 0: Not a Combination Product	02/06/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/06/2025

Labeler - GNL BRANDS INTERNATIONAL, LLC (099638248)