Label: MULTI EFFECT DAY CREAM SPF 25- octinoxate, octocrylene, octisalate, avobenzone, homosalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69435-1701-1 - Packager: Sano International Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 16, 2017
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PRINCIPAL DISPLAY PANEL
To Use: Smooth onto face.
For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply 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 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. -
INGREDIENTS AND APPEARANCE
MULTI EFFECT DAY CREAM SPF 25
octinoxate, octocrylene, octisalate, avobenzone, homosalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69435-1701 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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:69435-1701-1 50 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/29/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/23/2016 Labeler - Sano International Ltd. (514678390) Registrant - Peer Pharma Ltd. (514678390) Establishment Name Address ID/FEI Business Operations Peer Pharma Ltd. 514678390 manufacture(69435-1701) Establishment Name Address ID/FEI Business Operations Sano International Ltd. 600395487 label(69435-1701)