PATRICKS SUNSCREEN - avobenzone, octinoxate, octocrylene, oxybenzone lotion
O.P. Products, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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

Place holder text.

image of front of package image of back of package

PATRICKS SUNSCREEN
avobenzone, octinoxate, octocrylene, oxybenzone lotion

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/28/2011

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

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

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

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