Marine Screen Mineral Sunscreen Broad Spectrum Spf 50 Lotion
FDA Label NDC 73432-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Osea International, Llc for the product Marine Screen Mineral Sunscreen Broad Spectrum Spf 50 (NDC 73432-004). 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 ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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 Ingredient

Zinc Oxide 19.65%

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 sun.

Warnings

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally to face & neck 15 minutes before sun exposure and as needed.
  • Reapply at least every 2 hours.
  • Use water-resistant sunscreen if swimming or sweating.
  • 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 10AM - 2PM.
    • Wear long-sleeve shirts, pants, hats, and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

WATER / AQUA / EAU, C13-15 ALKANE, BUTYLOCTYL SALICYLATE, ETHYLHEXYL OLIVATE, GLYCERIN, ZEA MAYS (Corn) STARCH, ARGANIA SPINOSA KERNEL OIL, PROPANEDIOL, TOCOPHERYL ACETATE, POLYHYDROXYSTEARIC ACID, INULIN LAURYL CARBAMATE, PENTYLENE GLYCOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PHENOXYETHANOL, SODIUM ACRYLATES CROSSPOLYMER-2, BISABOLOL, LAUROYL LYSINE, EUGENIA CARYOPHYLLUS (Clove) BUD EXTRACT, SQUALANE, SOLIDAGO VIRGAUREA (Goldenrod) EXTRACT, TOCOPHEROL, BETAINE, PANTHENOL, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, POLYGLYCERYL-3 DIISOSTEARATE, CELLULOSE, ETHYLHEXYLGLYCERIN, 1,2-HEXANEDIOL, SORBITAN ISOSTEARATE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, BIOSACCHARIDE GUM-4, UNDARIA PINNATIFIDA EXTRACT, SODIUM HYALURONATE

Other

Dist. by
OSEA Intl. LLC
Malibu, CA 90265

Principal Display Panel - 50 Ml Tube Carton

NEW

OSEA

marine sunscreen™

SPF
50

hydrating emulsion
mineral face sunscreen
broad spectrum SPF 50

1.69 fl. oz. / 50 mL

Principal Display Panel (50 mL Tube Carton)

Principal Display Panel (50 mL Tube Carton)

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