Ocean Potion Suncare Mineral 30 Zinc Oxide Sunscreen Lotion
FDA Label NDC 85638-004

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 30 Zinc Oxide Sunscreen (NDC 85638-004). 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, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., 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

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,
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

Op86114a (Op86114a)

Op86114a (Op86114a)

Op86115a (Op86115a)

Op86115a (Op86115a)

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