MAX SHEER ALL DAY MOISTURE DEFENSE- sunscreen lotion spf 30 lotion 
Peter Thomas Roth Labs LLC

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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Peter Thomas Roth Max Sheer All Day Moisture Defense Lotion Sunscreen SPF 30

Drug Facts

Active Ingredients

Avobenzone 3%
Homosalate 10%
Octinoxate 7.5%
Octisalate 5%
Octocrylene 2%
Oxybenzone 6%

Purpose

Sunscreen

Uses

Warnings

For external use only

When using this product

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

Directions

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Ascorbyl Palmitate, Bentonite, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carbomer, Ceramide 3, Cetyl Alcohol, Dimethicone, Ginkgo Biloba Leaf Extract, Glyceryl Stearate, Panthenol, PEG-100 Stearate, Phenoxyethanol, Phospholipids, Potassium Sorbate, Propylene Glycol, Retinyl Palmitate, Sodium Benzoate, Stearic Acid, Tetrasodium EDTA, Tocopheryl Acetate, Triethanolamine, Water/Aqua/Eau.

Other Information

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-PTR-SKIN (787-7546)

PRINCIPAL DISPLAY PANEL

Max Sheer All Day Moisture Defense Carton54031-324-03 BOTTLE - 15ML54031-324-04 BOTTLE - 30ML54031-324-05 BOTTLE - 50ML

MAX SHEER ALL DAY MOISTURE DEFENSE 
sunscreen lotion spf 30 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54031-324
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE.001 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE.0008 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE.0006 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE.0005 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE.0003 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE.0002 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.0048 g  in 1 mL
Propylene Glycol (UNII: 6DC9Q167V3) 0.0004 g  in 1 mL
GLYCERYL 1-STEARATE (UNII: 258491E1RZ) 0.0003 g  in 1 mL
PEG-100 Stearate (UNII: YD01N1999R) 0.00025 g  in 1 mL
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) 0.0003 g  in 1 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 0.0002 g  in 1 mL
Palmitic Acid (UNII: 2V16EO95H1) 0.0002 g  in 1 mL
Phenoxyethanol (UNII: HIE492ZZ3T) 0.0001 g  in 1 mL
Stearic Acid (UNII: 4ELV7Z65AP) 0.0001 g  in 1 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.0001 g  in 1 mL
Bentonite (UNII: A3N5ZCN45C) 0.000025 g  in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.000025 g  in 1 mL
Dimethicone (UNII: 92RU3N3Y1O) 0.000025 g  in 1 mL
Allantoin (UNII: 344S277G0Z) 0.00002 g  in 1 mL
PEG-8 Dimethicone (UNII: GIA7T764OD) 0.000014 g  in 1 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.00001 g  in 1 mL
Cetyl Alcohol (UNII: 936JST6JCN) 0.00001 g  in 1 mL
Panthenol (UNII: WV9CM0O67Z) 0.00001 g  in 1 mL
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) 0.0000087 g  in 1 mL
EDETATE SODIUM (UNII: MP1J8420LU) 0.0000084 g  in 1 mL
Myristic Acid (UNII: 0I3V7S25AW) 0.000006 g  in 1 mL
Potassium Sorbate (UNII: 1VPU26JZZ4) 0.0000025 g  in 1 mL
Sodium Benzoate (UNII: OJ245FE5EU) 0.0000025 g  in 1 mL
Arachidic Acid (UNII: PQB8MJD4RB) 0.000002 g  in 1 mL
Lauric Acid (UNII: 1160N9NU9U) 0.000002 g  in 1 mL
Ascorbic Acid (UNII: PQ6CK8PD0R) 0.000001 g  in 1 mL
Octyldodecanol (UNII: 461N1O614Y) 0.000001 g  in 1 mL
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.000001 g  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.000001 g  in 1 mL
Sodium Propoxyhydroxypropyl Thiosulfate Silica (UNII: 208G222332) 0.000001 g  in 1 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.000001 g  in 1 mL
Ceramide NP (UNII: 4370DF050B) 0.00000099 g  in 1 mL
Butylene Glycol (UNII: 3XUS85K0RA) 0.000000395 g  in 1 mL
GINKGO (UNII: 19FUJ2C58T) 0.0000002 g  in 1 mL
Butyl Acetate (UNII: 464P5N1905) 0.000000001 g  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54031-324-011 in 1 CARTON07/29/2013
1NDC:54031-324-001 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:54031-324-0315 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/29/2013
3NDC:54031-324-0430 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/29/2013
4NDC:54031-324-061 in 1 CARTON07/29/2013
4NDC:54031-324-0550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/29/2013
Labeler - Peter Thomas Roth Labs LLC (780458944)
Registrant - Peter Thomas Roth Labs LLC (780458944)
Establishment
NameAddressID/FEIBusiness Operations
June Jacobs Labs LLC082439410manufacture(54031-324)

Revised: 6/2016
Document Id: 32608f19-e419-4194-ad8a-759458484d77
Set id: 21a30d5f-7048-48a8-88ed-c529653296c7
Version: 7
Effective Time: 20160628
 
Peter Thomas Roth Labs LLC