NDC | 54031-324-00, 54031-324-01, 54031-324-03, 54031-324-04, 54031-324-05, 54031-324-06 |
Set ID | 21a30d5f-7048-48a8-88ed-c529653296c7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Peter Thomas Roth Labs LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Drug Facts
- Purpose
- Warnings
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if involved in swimming or intense physical activities where sweating will occur
- reapply at least every 2 hours
- 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 in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
-
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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MAX SHEER ALL DAY MOISTURE DEFENSE
sunscreen lotion spf 30 lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54031-324 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:54031-324-01 1 in 1 CARTON 07/29/2013 1 NDC:54031-324-00 1 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:54031-324-03 15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/29/2013 3 NDC:54031-324-04 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/29/2013 4 NDC:54031-324-06 1 in 1 CARTON 07/29/2013 4 NDC:54031-324-05 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/29/2013 Labeler - Peter Thomas Roth Labs LLC (780458944) Registrant - Peter Thomas Roth Labs LLC (780458944) Establishment Name Address ID/FEI Business Operations June Jacobs Labs LLC 082439410 manufacture(54031-324)