Elf Lip Balm Spf 15
FDA Label NDC 52664-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hangzhou Facecare Cosmetics Co., Ltd. for the product Elf Lip Balm Spf 15 (NDC 52664-008). 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:

Benzophenone-3: 4.5%

Ethylhexyl Methoxycinnamate: 5.0%

Otc - Purpose

Purpose:

Sunscreen

Indications & Usage

Uses:

Applying on lip area helps prevent sunburn

Warnings

Warning:

For external use only

Otc - When Using

When Using This Product:

Avoid contact with eyes. If contact occurs rinse eyes thoroughly with water

Otc - Ask Doctor

Stop Use and Ask A Doctor If:

Rash or irritation develops and lasts

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:

Apply liberally as often as needed before sun exposure.

Reapply as needed or after swimming or towel drying

Storage And Handling

Other InformationStore at room temperature 20-25 C (77-86F)

Inactive Ingredient

Inactive Ingredient:

Paraffinium Liquidum (Mineral Oil), hydrogenated Polyisobutene, Polyethylene Wax, Ceresine Wax, Copernicia Cerifera (Carnauba) Wax, Microcrystalline Wax, Mentha Piperita (Peppermint) Oil, Phenoxyethanol,  Methylparaben, Butylparaben, Ethylparaben, Propylparaben.


Package Label.Principal Display Panel

labe

Label (Lip)

Label (Lip)

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