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. ---------- 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. PATRICKS SUNSCREEN avobenzone, octinoxate, octocrylene, oxybenzone lotion Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:40 0 6 1-9 9 0 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avo benzo ne (UNII: G6 3QQF2NOX) (Avo benzo ne - UNII:G6 3QQF2NOX) Avo benzo ne 2 g in 10 0 g O ctino xa te (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51) Octino xate 7.25 g in 10 0 g O cto crylene (UNII: 5A6 8 WGF6 WM) (Octo crylene - UNII:5A6 8 WGF6 WM) Octo crylene 9 .75 g in 10 0 g O xybenzo ne (UNII: 9 5OOS7VE0 Y) (Oxybenzo ne - UNII:9 5OOS7VE0 Y) Oxybenzo ne 3 g in 10 0 g Inactive Ingredients Ingredient Name Strength Wa ter (UNII: 0 59 QF0 KO0 R) Alkyl (C12 -15) Benzo a te (UNII: A9 EJ3J6 1HQ) Alo e Vera Lea f (UNII: ZY8 1Z8 3H0 X) Iso do deca ne (UNII: A8 28 9 P6 8 Y2) Pheno xyetha no l (UNII: HIE49 2ZZ3T) Edeta te So dium (UNII: MP1J8 420 LU) Ca rbo mer Co po lymer Type A (UNII: 71DD5V9 9 5L) Tro la mine (UNII: 9 O3K9 3S3TK) So rbita n Mo no o lea te (UNII: 0 6 XEA2VD56 ) Alpha -To co phero l Aceta te (UNII: 9 E8 X8 0 D2L0 ) Vita min A Pa lmita te (UNII: 1D1K0 N0 VVC) Selenicereus Gra ndiflo rus Flo wer (UNII: II8 77K4UNR) Product Characteristics Color white Score Shape Siz e Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40 0 6 1-9 9 0 -0 8 8 in 1 CELLO PACK 1 NDC:40 0 6 1-9 9 0 -10 8 .75 g in 1 PACKET 2 NDC:40 0 6 1-9 9 0 -50 50 in 1 BOX 2 NDC:40 0 6 1-9 9 0 -10 8 .75 g in 1 PACKET 3 NDC:40 0 6 1-9 9 0 -11 8 .75 g in 1 PACKET Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph final part352 0 4/28 /20 11 Labeler - O.P. Products, Inc. (840571231) Establishment Name Addre ss ID/FEI Busine ss Ope rations O.P. Pro ducts, Inc. 8 40 571231 relabel Establishment Name Addre ss ID/FEI Busine ss Ope rations G.A.R. Labo rato ries, Inc. 0 749 336 15 manufacture Establishment Name Addre ss ID/FEI Busine ss Ope rations LICO Industries, LLC 0 9 8 0 0 9 0 41 repack Revised: 1/2012 O.P. Products, Inc..