Miracle Worker SPF 55

Dosage form: cream
Ingredients: AVOBENZONE 1.5mL in 50mL, HOMOSALATE 5mL in 50mL, OCTISALATE 2.5mL in 50mL, OCTOCRYLENE 1mL in 50mL, OXYBENZONE 3mL in 50mL
Labeler: Philosophy, Inc
NDC Code: 50184-6500

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

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

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

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

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

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

HELPS PREVENT SUNBURN

HIGHER SPF GIVES MORE PROTECTION

FOR EXTERNAL USE ONLY

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN.  IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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

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.

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MIRACLE WORKER SPF 55 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-6500
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE1.5 mL  in 50 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE5 mL  in 50 mL
OCTISALATE (OCTISALATE) OCTISALATE2.5 mL  in 50 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE1 mL  in 50 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE3 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 
DIMETHICONE 
HEXYLDECANOL 
BRASSICA RAPA VAR. RAPA 
ALOE VERA LEAF 
SODIUM ASCORBYL PHOSPHATE 
WHEAT GERM 
GLYCERIN 
LEVOMENOL 
ALPHA-TOCOPHEROL 
VITAMIN A PALMITATE 
.ALPHA.-TOCOPHEROL ACETATE, D- 
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 
LAURYL GLUCOSIDE 
TITANIUM DIOXIDE 
BENTONITE 
STEARIC ACID 
EDETATE DISODIUM 
ETHYLHEXYLGLYCERIN 
PHENOXYETHANOL 
CHLORPHENESIN 
TETRAPEPTIDE-21 
PICEA ABIES WOOD 
CETYLHYDROXYPROLINE PALMITAMIDE 
SODIUM POLYACRYLATE (8000 MW) 
Packaging
#Item CodePackage Description
1NDC:50184-6500-150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/19/2010
Labeler - Philosophy, Inc (948102256)
Establishment
NameAddressID/FEIOperations
AMCOL Health and Beauty Solutions, Inc.148997310manufacture

Revised: 01/2011
 
Philosophy, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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