![XXL SUN BLOCK SPF 50 (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE CREAM) CREAM [PEER PHARMA LTD.]](https://medic.hrt.org//dailymed/images/6cf6cd4b-7be7-6bad-e053-2991aa0a2020/sun block.jpg)
| NDC | 69435-1804-1 |
| Set ID | 6cf6cd4b-7be7-6bad-e053-2991aa0a2020 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Peer Pharma Ltd. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
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PRINCIPAL DISPLAY PANEL
Directions for Use: Apply generously to face and body regularly before sun exposure and as needed.
Reapply: after 40 minutes before of or 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.
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INGREDIENTS AND APPEARANCE
XXL SUN BLOCK SPF 50
octinoxate, octocrylene, octisalate, avobenzone, homosalate, titanium dioxide cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69435-1804 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength JOJOBA OIL (UNII: 724GKU717M) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALMOND OIL (UNII: 66YXD4DKO9) DMDM HYDANTOIN (UNII: BYR0546TOW) ALLANTOIN (UNII: 344S277G0Z) CHLORPHENESIN (UNII: I670DAL4SZ) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) ISOHEXADECANE (UNII: 918X1OUF1E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) SHEA BUTTER (UNII: K49155WL9Y) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) NIACINAMIDE (UNII: 25X51I8RD4) DIMETHICONE (UNII: 92RU3N3Y1O) SEA SALT (UNII: 87GE52P74G) ALOE VERA LEAF (UNII: ZY81Z83H0X) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PANTHENOL (UNII: WV9CM0O67Z) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) AVOCADO OIL (UNII: 6VNO72PFC1) WATER (UNII: 059QF0KO0R) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69435-1804-1 100 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/24/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/24/2018 Labeler - Peer Pharma Ltd. (514678390) Registrant - Peer Pharma Ltd. (514678390) Establishment Name Address ID/FEI Business Operations Peer Pharma Ltd. 514678390 manufacture(69435-1804)