Color Correcting Swirl Foundation Broad Spectrum Spf 25
FDA Label NDC 51389-121

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laura Geller Make Up Inc. for the product Color Correcting Swirl Foundation Broad Spectrum Spf 25 (NDC 51389-121). 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, use, warnings, when using this product, stop use and ask a doctor, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Use

→ Warnings

→ When Using This Product

→ Stop Use And Ask A Doctor

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

Active Ingredients

Octocrylene 5%

Avobenzone 3%

Octisalate 3%

Purpose

Sunscreen

Use

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.

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 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 generously 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply 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 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
- Children under 6 months of age: Ask a doctor.

Other Information

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

Inactive Ingredients

Isostearyl Neopentanoate, Isohexadecane, C12-15 Alkyl Benzoate, Butylene Glycol Cocoate, Titanium Dioxide, Hydrogenated Castor Oil, Polymethyl Methacrylate, Cetearyl Ethylhexanoate, Mica, Silica, Ceresin, Silica Dimethyl Silylate, Ascorbyl Tetraisopalmitate, Tocopheryl Acetate, PPG-15 Stearyl Ether, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Caprylic/Capric Triglyceride, Isopropyl Myristate, Plankton Extract, Glycine Soja Oil (Glycine Soja (Soybean) Oil), Tribehenin, Retinyl Palmitate, Carthamus Tinctorius Seed Oil (Carthamus Tinctorius (Safflower) Seed Oil),Linoleic Acid, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide

MAY CONTAIN: Titanium Dioxide, Iron Oxide, Iron Oxide, Ultramarines, Yellow 5 Lake, Yellow 6 Lake