Elf Flawless Finish Foundation Oil Free Spf 15 Sunscreen Light Ivory
FDA Label NDC 76354-631

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by E.l.f. Cosmetics, Inc for the product Elf Flawless Finish Foundation Oil Free Spf 15 Sunscreen Light Ivory (NDC 76354-631). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient:

Titanium Dioxide: 4.45%

Octinoxate: 4.0%

Octisalate: 3.0%

Otc - Purpose

Purpose:

Sunscreen

Indications & Usage

Uses:

Helps prevent sunburn

Warnings

Warning:

For external use only

Skin Cancer/ Skin Aging Alert:

Spending time in the sun increases your increases your risk of sking cancer or early skin aging. This product has been shown only to help prevent sunburn not sking cancer or skin aging.

Otc - When Using

When using this product:

Keep out of eyes. Rinse with water to remove.

Otc - Ask Doctor

Stop Use and Ask a Doctor if:

Rash occurs

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of Children

Dosage & Administration

Directions:

For suncreen use:

Apply generally 15 min before sun exposure.

Children under six months of age: ask a doctor

Reapply at least every two hours.

Use a water resistant sunscreen if swimming or sweating

Sun Protection Measures:

Spending time in sun increases your risk of skin cancer or early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including

  • Limit time in the sun, especially from 10 am to 2 pm
  • Wear long sleeved shirts, pants, hats, and sunglasses.
  • Children under six months of age: ask a doctor

    • Other Information:

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

    Store at room temperature 15C-30C (59F-86F)

Inactive Ingredient

Inactive Ingredient:

Water (Aqua), Glycerin, Isododecane, Dimethicone, Cyclopentasiloxane, Propylene Glycol, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Tridecyl Trimellitate, Sorbitan Sesquioleate, Cyclohexasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Polymethyl Methacrylate, Boron Nitride, Magnesium Sulfate, Magnesium Stearate, PEG/PPG-15/15 Dimethicone, Disteardimonium Hectorite, Silica Dimethyl Silylate, Aluminum Hydroxide, Triethoxycaprylylsilane, Silica, Alumina, Fragrance (Parfum), Phenoxyethanol, Caprylyl Glycol, EthylhexylglycerinMA

May contain:

Iron Oxides (CI 77491, CI 77492, CI 77499)

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