Mally Face Defender Foundation Bb
FDA Label NDC 76119-1444

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mallygirl, Llc for the product Mally Face Defender Foundation Bb (NDC 76119-1444). 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, otc - do not use, otc - stop use, otc - when using, 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 Ingredients

→ Purpose

→ Use

→ Warnings

→ Otc - Do Not Use

→ Otc - Stop Use

→ Otc - When Using

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Other Information

→ Other

→ Principal Display Panel

Active Ingredients

Titanium Dioxide 4.50%

Zinc Oxide 3.00%

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

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Stop Use

Stop use and ask doctor if rash occurs.

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

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

Directions

Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: ask a doctor
Sun Protection Measures. Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higer and other sun protection measures including
Limit time in the sun especially from 10:00 a.m. - 2:00 p.m.
Wear long sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

Water (Aqua), Cyclopentaslloxane, Octyldodecyl Neopentanoate, Butylene Glycol, Glycerin, Polyglyceryl-4 Isostearate, Dimethicone Crosspolymer, PEG/PPG 18/18 Dimethicone, Silica, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Stearic Acid, Aluminum Hydroxide, Sodium Dehydroacetate, Phytantriol, Hexyl Laurate, Triethoxycaprylylsilane, Nylon-12, Carbomer, Polysorbate 20, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Sodium Chloride, Tocopherol, Tetrahexyldecyl Ascorbate, Nylon-12 Fluorescent Brightener 230 Salt, Polyvinylalconol Crosspolymer, Magnesium Chloride, Potassium Chloride, Zinc Chloride, Lysine, Sodium Hyaluronate, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, May Contain: Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)