Miracle Worker Spf 55
FDA Label NDC 50184-6500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Philosophy, Inc for the product Miracle Worker Spf 55 (NDC 50184-6500). 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, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

AVOBENZONE (3.00%)........SUNSCREEN

HOMOSALATE (10.00%)......SUNSCREEN

OCTISALATE (5.00%)...........SUNSCREEN

OCTOCRYLENE (2.00%).......SUNSCREEN

OXYBENZONE (6.00%).........SUNSCREEN

Otc - Purpose

HELPS PREVENT SUNBURN

HIGHER SPF GIVES MORE PROTECTION

Warnings

FOR EXTERNAL USE ONLY

Otc - When Using

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

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 RIGHT AWAY.

Indications & Usage

APPLY LIBERALLY TO CLEAN, DRY FACE IN THE MORNING BEFORE SUN EXPOSURE AND AS NEEDED.  CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

Inactive Ingredient

WATER (AQUA), BUTYLENE GLYCOL, PEG-8, POLYETHYLENE, DIMETHICONE, TETRAPEPTIDE-21, HEXYLDECANOL, PICEA EXCELSA WOOD EXTRACT, BRASSICA CAMPESTRIS (RAPESEED) STEROLS, ALOE BARBADENSIS LEAF JUICE, SODIUM ASCORBYL PHOSPHATE, CETYLHYDROXYPROLINE PALMITAMIDE, TRITICUM VULGARE (WHEAT) GERM EXTRACT, GLYCERIN, BISABOLOL, TOCOPHEROL, RETINYL PALMITATE, TOCOPHERYL ACETATE, SODIUM POLYACRYLATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, LAURYL GLUCOSIDE, TITANIUM DIOXIDE, BENTONITE, STEARIC ACID, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, CHLORPHENESIN.

Package Label.Principal Display Panel

Mm1 (Mwspf55)

Mm1 (Mwspf55)

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