HELP ME BROAD SPECTRUM SPF 30 SUNSCREEN RETINOL DAY TREATMENT LOTION- avobenzone liquid 
Philosophy Inc.

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.

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DRUG FACTS

Avobenzone 2.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 1.5%

Oxybenzone 4.0%

Avobenzone: Sunscreen

Homosalate: Sunscreen

Octisalate: Sunscreen

Octocrylene: Sunscreen

Oxybenzone: Sunscreen

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

For external use only.

Do not use on damaged or broken skin. If sensitive to retinol, use once every 2-3 days build to a daily use as tolerated.

When using this product keep out of eyes, rinse with water to remove.

Stop use and ask a doctor if rash occurs.

                                 
                               limit time int he sun, especially from 10 a.m.-2 p.m.
                               wear long sleeve shirts, pants, hats and sunglasses
                               ask a doctor. this product should NOT be used on children of any age.

water, c12-15 alkyl benzoate, butylene glycol, glycerin, potassium cetyl phosphate, methyl methacrylate/glycol dimethacrylate crosspolymer, arachidyl alcohol, dimethicone, glyceryl myristate, peg-100 stearate, sodium hyaluronate, retinol, picea abies wood extract, ethylhexylglycerin, tocopheryl acetate, dipotassium glycyrrhizate, arachidyl glucoside, bentonite, allyl methacrylates crosspolymer, acrylates/c10-30 alkyl acrylate crosspolymer, behenyl alcohol, sodium hydroxide, disodium edta, bht, erythorbic acid, polysorbate 20, chlorphenesin, titanium dioxide, phenoxyethanol.

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HELP ME  BROAD SPECTRUM SPF 30 SUNSCREEN RETINOL DAY TREATMENT LOTION
avobenzone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-1000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.6 mL  in 30 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate3 mL  in 30 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate1.5 mL  in 30 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.45 mL  in 30 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone1.2 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
butylene glycol (UNII: 3XUS85K0RA)  
glycerin (UNII: PDC6A3C0OX)  
potassium cetyl phosphate (UNII: 03KCY6P7UT)  
arachidyl alcohol (UNII: 1QR1QRA9BU)  
dimethicone (UNII: 92RU3N3Y1O)  
glyceryl myristate (UNII: 6992Y81827)  
peg-100 stearate (UNII: YD01N1999R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
retinol (UNII: G2SH0XKK91)  
PICEA ABIES FLOWER BUD (UNII: WQZ50FAU2B)  
ethylhexylglycerin (UNII: 147D247K3P)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
arachidyl glucoside (UNII: 6JVW35JOOJ)  
bentonite (UNII: A3N5ZCN45C)  
DOCOSANOL (UNII: 9G1OE216XY)  
sodium hydroxide (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
erythorbic acid (UNII: 311332OII1)  
polysorbate 20 (UNII: 7T1F30V5YH)  
chlorphenesin (UNII: I670DAL4SZ)  
titanium dioxide (UNII: 15FIX9V2JP)  
phenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50184-1000-130 mL in 1 BOX
2NDC:50184-1000-230 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2012
Labeler - Philosophy Inc. (948102256)
Registrant - Philosophy Inc. (948102256)
Establishment
NameAddressID/FEIBusiness Operations
Bio Tech Research Labs948102256manufacture

Revised: 4/2012
Document Id: 438aff74-9816-41f3-967b-0c02dc008179
Set id: b0dd8248-424d-44cb-a037-f2d894c8ec3a
Version: 1
Effective Time: 20120411
 
Philosophy Inc.