Daily Moisturizing SPF 15: Package Insert and Label Information

DAILY MOISTURIZING SPF 15- octinoxate, octisalate and oxybenzone 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.

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:

Outer Package
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Inner Package
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 30 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SQUALANE
C12-13 PARETH-23
C12-13 PARETH-3
XANTHAN GUM
CAPRYLYL GLYCOL
PHENOXYETHANOL
ANHYDROUS DEXTROSE
CHONDRUS CRISPUS
ETHYLHEXYLGLYCERIN
STEARYL ALCOHOL
TRIBEHENIN
POTASSIUM CETYL PHOSPHATE
HYDROGENATED PALM GLYCERIDES
GLYCERIN
C13-14 ISOPARAFFIN
LAURETH-7
CETYL PALMITATE
METHYLPARABEN
BUTYLPARABEN
ETHYLPARABEN
PROPYLPARABEN
.ALPHA.-TOCOPHEROL ACETATE
PROPYLENE GLYCOL
DIAZOLIDINYL UREA
IODOPROPYNYL BUTYLCARBAMATE
ALLANTOIN
HYALURONATE SODIUM
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW)
ROSEMARY
SODIUM ASCORBYL PHOSPHATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67226-2016-5 1 BOTTLE in 1 BOX contains a BOTTLE
1 55 mL in 1 BOTTLE This package is contained within the BOX (67226-2016-5)
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 Operations
Delta Pharma Inc. 200161730 manufacture (67226-2016)

Revised: 01/2020 Vivier Pharma, Inc.

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