Label: XXL SUN BLOCK SPF 50- octinoxate, octocrylene, octisalate, avobenzone, homosalate cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69435-1905-1 - Packager: Peer Pharma Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 6, 2019
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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 cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69435-1905 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4 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 13 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 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:69435-1905-1 100 mL in 1 CONTAINER; Type 0: Not a Combination Product 09/06/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/06/2019 Labeler - Peer Pharma Ltd. (514678390) Registrant - Peer Pharma Ltd. (514678390) Establishment Name Address ID/FEI Business Operations Peer Pharma Ltd. 514678390 manufacture(69435-1905)