DAILY MOISTURIZING SPF 15- octinoxate, octisalate, benzophenone cream 
Vivier Pharma Inc

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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Daily Moisturizing Cream SPF 15

DRUG FACTS

ACTIVE INGREDIENTS

  • 7.5%  Octinoxate
  • 3.0%  Octyl Salicylate
  • 3.0%  Benzophenone

PURPOSE

Sunscreen

USES

  • Moisturizing cream with sunscreen.
  • Helps prevent sunburn and provides a sun protection factor of 15.

WARNINGS

For external use only

When using this product

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Do not use

on damaged or broken skin.

Stop use and ask a doctor if

  • Rash or irritation develops and lasts.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

  • Apply to clean, dry skin, liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing.
  • For use on children less than 6 months of age, consult a healthcare practitioner.
  • Use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENTS

WATER/EAU, SQUALANE, DIVINYLDIMETHICONE/DIMETHICONE COPOLYMER, C12-13 PARETH-23, C12-13 PARETH-3, XANTHAN GUM, CAPRYLYL GLYCOL, PHENOXYETHANOL, GLUCOSE, CARRAGEENANS (CHONDRUS CRISPUS), ETHYLHEXYLGLYCERIN, STEARYL ALCOHOL, TRIBEHENIN, POTASSIUM CETYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, GLYCERIN, GLYCERYL POLYACRYLATE, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, CETYL PALMITATE, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, TOCOPHERYL ACETATE, PROPYLENE GLYCOL, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE, ALLANTOIN, SODIUM HYALURONATE, HYDROLYZED GLYCOSAMINOGLYCANS, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, SODIUM ASCORBYL PHOSPHATE

Questions?

450 455 9779     1 877 484 8437

Package Labeling:

OuterJarBottomJar

DAILY MOISTURIZING SPF 15 
octinoxate, octisalate, benzophenone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
BENZOPHENONE (UNII: 701M4TTV9O) (BENZOPHENONE - UNII:701M4TTV9O) BENZOPHENONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SQUALANE (UNII: GW89575KF9)  
C12-13 PARETH-23 (UNII: J1WW1510L4)  
C12-13 PARETH-3 (UNII: DMC6N3419L)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
ALLANTOIN (UNII: 344S277G0Z)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ROSEMARY (UNII: IJ67X351P9)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67226-2015-548 mL in 1 JAR; Type 0: Not a Combination Product11/11/201711/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/11/201711/30/2019
Labeler - Vivier Pharma Inc (250996550)

Revised: 1/2020
 
Vivier Pharma Inc