MAX BLOCK SPF 30 SUNSCREEN SPORT- octinoxate, octisalate, and oxybenzone lotion

MAX BLOCK by

Drug Labeling and Warnings

MAX BLOCK by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.5 %, Octisalate 5.0 %, and Oxybenzone 4.0 %

Purpose

Sunscreen

Uses

• helps prevent sunburn.

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

Directions

• Spray liberally and spread evently by hand 15 minutes before sun exposure.
• Do not spray directly into face. Spray on hands then apply to face
• reapply: after 80 minutes of swimming or sweating
• immediately after towel dryin at least every 2 hours
• children under 6 months: Ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkylmethacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, Diazolidinyl Urea, Dimethicone, Disodium EDTA, Fragrance, Isopropylphthalimide, Methylparaben, Oleth 10, Propylene Glycol, Propylparaben, Sorbitan Oleate, Tocopheryl Acetate, Triethanolamine, Trimethylsiloxysilicate, Water

Other Information:

• protect this product from excesive heat and direct sun

PRINCIPAL DISPLAY PANEL - 118 mL  Bottle Label

MAX

BLOCK

SPF

30

SPORT

SUNSCREEN SPRAY

with Aloe Vera

WATER RESISTANT (80 MINUTES)

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

MAX BLOCK  SPF 30 SUNSCREEN SPORT
octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	76.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	51 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
OLETH-10 (UNII: JD797EF70J)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0109-3	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/15/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/15/2013

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0109) , pack(58443-0109) , manufacture(58443-0109) , analysis(58443-0109)