MIRACLE WORKER SPF 55- avobenzone, homosalate, octisalate, octocrylene and oxybenzone cream

Miracle Worker SPF 55 by

Drug Labeling and Warnings

Miracle Worker SPF 55 by is a Otc medication manufactured, distributed, or labeled by Philosophy, Inc, AMCOL Health and Beauty Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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

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

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

PURPOSE

HELPS PREVENT SUNBURN

HIGHER SPF GIVES MORE PROTECTION

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

ASK DOCTOR

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

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.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

MIRACLE WORKER SPF 55 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50184-6500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 mL  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 mL  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 mL  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 mL  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYLDECANOL (UNII: 151Z7P1317)
BRASSICA RAPA VAR. RAPA (UNII: AIV6895O8B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
WHEAT GERM (UNII: YR3G369F5A)
GLYCERIN (UNII: PDC6A3C0OX)
LEVOMENOL (UNII: 24WE03BX2T)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BENTONITE (UNII: A3N5ZCN45C)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
TETRAPEPTIDE-21 (UNII: 179JUC43HU)
PICEA ABIES WOOD (UNII: 72GZ8K8996)
CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50184-6500-1	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/19/2010

Labeler - Philosophy, Inc (948102256)

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health and Beauty Solutions, Inc.		148997310	manufacture