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

help me by

Drug Labeling and Warnings

help me by is a Otc medication manufactured, distributed, or labeled by Philosophy Inc., Bio Tech Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 2.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 1.5%

Oxybenzone 4.0%

PURPOSE

Avobenzone: Sunscreen

Homosalate: Sunscreen

Octisalate: Sunscreen

Octocrylene: Sunscreen

Oxybenzone: Sunscreen

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

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  

WARNINGS

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.

DOSAGE & ADMINISTRATION

• apply liberally 15 minutes before sun exposure on clean dry skin, avoiding the eye area
• reapply at least every 2 hours when using as a sunscreen
• Sun Protection Measures. spending time in the sun increases your risk of skin cancer and early skin aging. to decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  

                                 
                               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.

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HELP ME  BROAD SPECTRUM SPF 30 SUNSCREEN RETINOL DAY TREATMENT LOTION
avobenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50184-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.6 mL  in 30 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	3 mL  in 30 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	1.5 mL  in 30 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.45 mL  in 30 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	1.2 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50184-1000-1	30 mL in 1 BOX
2	NDC: 50184-1000-2	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2012

Labeler - Philosophy Inc. (948102256)

Registrant - Philosophy Inc. (948102256)

Establishment
Name	Address	ID/FEI	Business Operations
Bio Tech Research Labs		948102256	manufacture