DAILY MOISTURIZING SPF 15- octinoxate, octisalate, oxybenzone cream

Daily Moisturizing SPF 15 by

Drug Labeling and Warnings

Daily Moisturizing SPF 15 by is a Otc medication manufactured, distributed, or labeled by Vivier Pharma, Inc., Dermolab Pharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Active ingredients

Octinoxate - 7.5%
Octyl Salicylate - 3%

Benzophenone-3 - 3%

Purpose

Sunscreen

Uses

Moisturizing cream with sunscreen. Helps prevent sunburn and provides a sun protection factor of 15. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. Ideal for daily use; can be applied under makeup.

Warnings

For external use only.

Do not use

on damaged or broken skin.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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 daily to face, neck and chest.  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.

Other information

Store at room temperature (15-30°C / 59-86°F).

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?

Call 1 877 484 8437

Package Labeling:

INGREDIENTS AND APPEARANCE

DAILY MOISTURIZING SPF 15 
octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67226-2016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
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)
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)
ROSEMARY (UNII: IJ67X351P9)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67226-2016-5	1 in 1 BOX	05/01/2019
1		55 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2019

Labeler - Vivier Pharma, Inc. (250996550)

Establishment
Name	Address	ID/FEI	Business Operations
Delta Pharma Inc.		200161730	manufacture(67226-2016)