MAX SHEER ALL DAY MOISTURE DEFENSE- sunscreen lotion spf 30 lotion

Max Sheer All Day Moisture Defense by

Drug Labeling and Warnings

Max Sheer All Day Moisture Defense by is a Otc medication manufactured, distributed, or labeled by Peter Thomas Roth Labs LLC, June Jacobs Labs LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

Uses

• 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

• Do not use on damaged or broken skin

When using this product

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

STOP USE

• Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

​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

protect this product from excessive heat and direct sun

​Questions or comments?

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

​PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAX SHEER ALL DAY MOISTURE DEFENSE 
sunscreen lotion spf 30 lotion

Product 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)