Ocean Potion Suncare Mineral 50 Essential Scent Of Sunshine Zinc Oxide Continuous Sunscreen Spray
FDA Label NDC 85638-008

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gnl Brands International, Llc for the product Ocean Potion Suncare Mineral 50 Essential Scent Of Sunshine Zinc Oxide Continuous Sunscreen (NDC 85638-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, flammable:, ​do not use, when using this product, stop use and ask doctor if​, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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, 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

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