COPPERTONE DEFEND AND CARE FACE CLEAR ZINC SPF 50- octinoxate, octisalate, zinc oxide lotion Bayer HealthCare LLC. 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. ---------- Coppertone Defend and Care Clear Zinc SPF 50 Drug Facts Active ingredients Octinoxate 7.5%, Octisalate 4.5%, Zinc Oxide 9.7% Purpose Sunscreen Use Use ■ helps prevent sunburn 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 product is swallowed, get medical help or contact a Poison Control Center right away. Directions ■ shake well before use ■ apply liberally 15 minutes before sun exposure ■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at least every 2 hours ■ 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-sleeve shirts, pants, hats, and sunglasses ■ children under 6 months: Ask a doctor Other information Other information ■ protect this product from excessive heat and direct sun ■ may stain or damage some fabrics or surfaces Inactive ingredients water, dicaprylyl ether, glycerin, polyester-27, styrene/acrylates copolymer, trilaureth-4 phosphate, cetearyl alcohol, beeswax, dimethicone, ammonium acryloyldimethyltaurate/vp copolymer, benzyl alcohol, glyceryl stearate, triethoxycaprylylsilane, chlorphenesin, disodium EDTA Questions? 1-866-288-3330 Package Display Panel New Coppertone® Sunscreen Lotion Defend & Care™ Clear Zinc 50 Advanced Invisible Protection Water Resistant (80 minutes) Broad Spectrum SPF 50 COPPERTONE DEFEND AND CARE FACE CLEAR ZINC SPF 50 octinoxate, octisalate, zinc oxide lotion Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:11523-7413 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 79 .5 mg in 1 mL O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W) OCTISALATE 47.7 mg in 1 mL ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 2.8 mg in 1 mL Inactive Ingredients Ingredient Name Strength STYRENE/ACRYLAMIDE CO PO LYMER (MW 50 0 0 0 0 ) (UNII: 5Z4DPO246 A) DIMETHICO NE (UNII: 9 2RU3N3Y1O) AMMO NIUM ACRYLO YLDIMETHYLTAURATE/VP CO PO LYMER (UNII: W59 H9 29 6 ZG) BENZYL ALCO HO L (UNII: LKG8 49 4WBH) TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E) CHLO RPHENESIN (UNII: I6 70 DAL4SZ) WATER (UNII: 0 59 QF0 KO0 R) DICAPRYLYL ETHER (UNII: 77JZM5516 Z) EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K) TRILAURETH-4 PHO SPHATE (UNII: M9 6 W2OLL2V) GLYCERIN (UNII: PDC6 A3C0 OX) CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S) Product Characteristics Color white (o ff white to light yello w) Score Shape Siz e Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-7413-2 8 8 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct 11/0 1/20 17 11/0 1/20 21 2 NDC:11523-7413-3 177 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 11/0 1/20 17 11/0 1/20 21 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 11/0 1/20 17 11/0 1/20 21 Labeler - Bayer HealthCare LLC. (112117283) Revised: 7/2019 Bayer HealthCare LLC..