Lip Protector Sunscreen Spf15
FDA Label NDC 51531-9480

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mary Kay Inc. for the product Lip Protector Sunscreen Spf15 (NDC 51531-9480). 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, indications & usage, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS: OCTINOXATE(7.5% W/W), ZINC OXIDE(3.395% W/W),OXYBENZONE(3%W/W)

Indications & Usage

DIRECTION: Apply liberally at least 15 minutes before sun exposure, alone or under lipstick. Reapply every one to three hours as needed and after swimming, eating or drinking .3


Warnings

WARNING : For external use only. Discontinue use if irritation or rash develops. For use under 6 month of age , consult your doctor. Keep out reach of children.


Inactive Ingredient

PETROLATUM , C12-15 ALKYL BENZOATE , PENTAETYTHRITYL TETRAISOSTEARATE , OZOKERITE , CERESIN , CETYL ALCOHOL , TOCOPHERYL ACETATE, POLYHYDROXYSTERAIC ACID,TOCOPEROL , GLYCINE SOJA (SOYBEAN) OIL , TRIETHOXYCAPRYLRLSILANE , YELLOW 5 LAKE , YELLOW 6 LAKE


Package Label.Principal Display Panel

 

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