PATRICKS SUNSCREEN- avobenzone, octinoxate, octocrylene, oxybenzone lotion

Patricks Sunscreen by

Drug Labeling and Warnings

Patricks Sunscreen by is a Otc medication manufactured, distributed, or labeled by O.P. Products, Inc., G.A.R. Laboratories, Inc., LICO Industries, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients.............

Avobenzone 2.0%, Octinoxate 7.25%, Octocrylene 9.75%, Oxybenzone 3.0%

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection
• High protection against sunburn and tanning
• Retains SPF after 40 minutes of activity in the water or sweating
  

Warnings

• For external use only. When using this product
• Keep out of eyes
• Rinse with warm water to remove.  Stop use and ask doctor if
• rash or irritation develops and lasts

Directions

• Apply liberally 30 minutes before sun exposure
• Children under 6 months of age consult a doctor
• Reapply as needed or after towel drying, swimming or sweating
  

Purpose

Purpose...............Sunscreen

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children.

Inactive ingredients

Water (Aqua), C12-15 Alkyl Benzoate, Acrylates/C12-22 Alkyl Methacrylate Copolymer (Waterproofing), Aloe Barbadensis (Aloe Vera) Leaf Juice, Isododecane, Phenoxyethanol (Preservative), Fragrance (Parfum), Tetrasodium EDTA, Carbomer, Triethanolamine, Sorbitan Oleate (Plant Derived), Tocopheryl Acetate (Vitamin E Acetate), Retinyl Palmitate (Vitamin A Palmitate), Cereus Grandiflorus (Cactus) Flower Extract, Methylisothiazolinone.

Questions or comments: 1-800-411-8801 . patrickssunscreen.com

PRINCIPAL DISPLAY PANEL

Place holder text.

INGREDIENTS AND APPEARANCE

PATRICKS SUNSCREEN 
avobenzone, octinoxate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40061-990
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	2 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.25 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	9.75 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Isododecane (UNII: A8289P68Y2)
Phenoxyethanol (UNII: HIE492ZZ3T)
Edetate Sodium (UNII: MP1J8420LU)
Carbomer Copolymer Type A (UNII: 71DD5V995L)
Trolamine (UNII: 9O3K93S3TK)
Sorbitan Monooleate (UNII: 06XEA2VD56)
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Selenicereus Grandiflorus Flower (UNII: II877K4UNR)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40061-990-08	8 in 1 CELLO PACK
1	NDC: 40061-990-10	8.75 g in 1 PACKET
2	NDC: 40061-990-50	50 in 1 BOX
2	NDC: 40061-990-10	8.75 g in 1 PACKET
3	NDC: 40061-990-11	8.75 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/28/2011

Labeler - O.P. Products, Inc. (840571231)

Establishment
Name	Address	ID/FEI	Business Operations
O.P. Products, Inc.		840571231	relabel

Establishment
Name	Address	ID/FEI	Business Operations
G.A.R. Laboratories, Inc.		074933615	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
LICO Industries, LLC		098009041	repack