Mimosa Lane Spf45 Cream
FDA Label NDC 84554-0006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by R&g Divergency Llc for the product Mimosa Lane Spf45 (NDC 84554-0006). 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 warnings, active ingredients, indications and usage, purpose, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Active Ingredients

Octinoxate 7.5%
Octisalate 3.0%
Zinc Oxide 8.0%

Indications And Usage

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Keep Out Of Reach Of Children

Keep out of reach of children

Directions

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying and 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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

water, cyclopentasiloxane, ethylhexyl isononanoate, butylene glycol, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, dimethicone, phenoxyethanol, sodium chloride, triethoxycaprylylsilane, dimethicone/PEF-10/15 crosspolymer, dimethicone/vinyl dimethicone crosspolymer, sodium hyaluronate, iodopropynyl butylcarbamate, ascorbyl palmitate, retinyl palmitate, tocopherol

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