Firmarine Moisturizer Spf 30 Lotion
FDA Label NDC 57913-2833

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Erno Laszlo, Inc. for the product Firmarine Moisturizer Spf 30 (NDC 57913-2833). 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 other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED IN U.S.A. BY ERNO LASZLO NEW YORK, NY 10001

Active Ingredients

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%

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.

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 product is swallowed, get medical help or contact a Poison Control center right away.

Directions

Apply liberally 15 minutes before sun exposure

  • reapply: after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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 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-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

Inactive Ingredients

Water, Butylene Glycol, Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Glyceryl Stearate, Cetearyl Alcohol, Behenyl Alcohol, Palmitic Acid, Stearic Acid, Lecithin, Lauryl Alcohol, Cetyl Alcohol, Myristyl Alcohol, Coco-Glucoside, Ethylhexylglycerin, Dimethicone, PEG-100 Stearate, Spirulina Maxima Extract, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis Leaf Extract, Phospholipids, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Algae Extract, Pullulan, Sodium Hyaluronate, Trifluoroacetyl Tripeptide-2, Sea Water, Carbomer, Dextran, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Disodium EDTA, O-Cymen-5-Ol, Phenoxyethanol, Fragrance, Blue 1, Ext Violet 2.

Other Information

  • protect this product from excessive heat and direct sun

Questions Or Comments?

Call toll free at 866-452-7956.

Principal Display Panel - 50 Ml Jar Carton

ERNO
LASZLO

NEW YORK

FIRMARINE™

MOISTURIZER SPF 30

50mL e 1.7 fl.oz.

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