Elf Broad Spectrum Spf 20 Sunscreen Dark Bb Cream
FDA Label NDC 76354-614

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by J. A. Cosmetics U.s. Inc for the product Elf Broad Spectrum Spf 20 Sunscreen Dark Bb Cream (NDC 76354-614). 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:

OCTINOXATE: 7.5%

OCTISALATE: 5.0%

OXYBENONE: 4.0%

Otc - Purpose

Purpose:

Sunscreen

Indications & Usage

Uses:

Help prevent sunburn

If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

Warning:

For external use only

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 - Ask Doctor

Stop Use and Ask a Doctor if:

Rash occurs

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center immediately

Dosage & Administration

Directions:

For sunscreen use:

Apply generously 15 min before sun exposure. Reapply 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

Inactive Ingredient

Inactive Ingredient:

Water, Glycerin, Propylene Glycol, C12-15 Akyl Benzoate, Titanium Dioxide, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Sorbitan Olivate, Polymethyl Methacrylate, Sodium Chloride, Quaternium-18, Bentonite, Triethoxycaprylsilane, Dimethicone, Zinc Stereate, Talc, VP/Hexadecene Copolymer, Bisabolol, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Mica, Silica, Phenoxyethanol, Ethylhexylglycerin, Methylisothiazolinone, Fragrance

May contain:

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

Package Label.Principal Display Panel

Label (83266 714)

Label (83266 714)

* Please review the disclaimer below.