MAESTRO UV SKIN DEFENSE PRIMER SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, octinoxate, octisalate cream

Maestro UV skin defense primer Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Maestro UV skin defense primer Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by BPS 60. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%
Octinoxate 7.5%
Octisalate 5%

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 on

damaged or broken skin

When using this product

keep out of eyes, Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• shake well before use
• apply liberally 15 minutes before sun exposure
• reaply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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 value 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-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: Ask a doctor

Other information

• protect the product in this container from excessive heat and direct sun

Inacitve ingredients

c12-15 alkyl benzoate, water, butylene glycol, methyl methacrylate crosspolymer polymethylsilsesquioxane, vinyl dimethicone/ methicone silsesquioxane crosspolymer, isononyl isononanoate, glycerin, dicaprylyl carbonate, pentylene glycol, polyglyceryl-6 polyricinoleate, fragrance, tocopherol, sodium chloride, phenoxyethanol, stearyl glycyrrhetinate, polyglyceryl-2 isostearate, limonene, benzyl salicylate, benzyl alcohol, linalool, tetrasodium EDTA, butylphenyl methylpropional, hexyl cinnamal

Package Labeling:

INGREDIENTS AND APPEARANCE

MAESTRO UV SKIN DEFENSE PRIMER SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70581-001
Route of Administration	TOPICAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.ALPHA.-HEXYLCINNAMALDEHYDE, (2E)- (UNII: E9947QRR9O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70581-001-30	1 in 1 BOX	04/06/2016
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/06/2016

Labeler - BPS 60 (272259304)

Establishment
Name	Address	ID/FEI	Business Operations
BPS 60		272259304	pack(70581-001)