MULTI EFFECT DAY CREAM SPF 25- octinoxate, octocrylene, octisalate, avobenzone, homosalate cream 
Sano International Ltd.

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.

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Multi Effect Day Cream SPF 25

Multi Effect Day Cream

Octinoxate 7%

Octocrylene 5%

Octisalate 5%

Avobenzone 3%

Homosalate 2%

Keep out of reach of children.

Provides SPF 25 protection

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.

Smooth on to face.

MULTI EFFECT DAY CREAM SPF 25 
octinoxate, octocrylene, octisalate, avobenzone, homosalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69435-1701-150 mL in 1 CONTAINER; Type 0: Not a Combination Product05/29/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/23/2016
Labeler - Sano International Ltd. (514678390)
Registrant - Peer Pharma Ltd. (514678390)
Establishment
NameAddressID/FEIBusiness Operations
Peer Pharma Ltd.514678390manufacture(69435-1701)
Establishment
NameAddressID/FEIBusiness Operations
Sano International Ltd.600395487label(69435-1701)

Revised: 11/2017
Document Id: 5e1a757c-35a2-5be1-e053-2a91aa0a81fa
Set id: 50afd836-72c1-36be-e054-00144ff88e88
Version: 2
Effective Time: 20171116
 
Sano International Ltd.