SUNSCREEN SPF 30- avobenzone , octinoxate , ensulizole lotion

Sunscreen by

Drug Labeling and Warnings

Sunscreen by is a Otc medication manufactured, distributed, or labeled by Vivier Pharma, Inc., Entreprise Importfab Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octinoxate 7.5%
Avobenzone 2.5% 
Ensulizole 2%

Purpose

Sunscreen

Uses

• Helps prevent sunburn and provides a sun protection factor of 30.
• 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 liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• For use on children less than 6 months of age, consult a healthcare practitioner.
• Use a water resistant sunscreen if swimming or sweating.
• 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses.

Other information

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

Inactive ingredients

Butylated Hydroxytoluene, Butylparaben, Carbomer, Cetyl Alcohol, Dimethicone, Disodium EDTA, D-Panthenol, Ethylparaben, Hydrogenated Palm Glycerides, Methylparaben, Octyldodecanol, Octyldodecyl Neopentanoate, Phenoxyethanol, Potassium Cetyl Phosphate, Propylene Glycol, Propylparaben, Sodium Hydroxide, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Water.

Questions?

Call 1 877 484 8437

Package Labeling:

INGREDIENTS AND APPEARANCE

SUNSCREEN  SPF 30
avobenzone , octinoxate , ensulizole lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67226-2031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
ETHYLPARABEN (UNII: 14255EXE39)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
METHYLPARABEN (UNII: A2I8C7HI9T)
OCTYLDODECANOL (UNII: 461N1O614Y)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67226-2031-9	90 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2018

Labeler - Vivier Pharma, Inc. (250996550)