SUNSCREEN SPF 30- avobenzone, octinoxate, ensulizole lotion
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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Sunscreen Lotion SPF 30

Active Ingredients

2.5% Avobenzone

5.5% Octinoxate

2.0% Phenylbenzimidazole-5-Sulfonic Acid

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Provides broad-spectrum UVA/UVB protection
• Ideal for daily use; can be applied under makeup
• Optimal for post-care or on sensitive skin

Warnings

For external use only

When using this product

Keep out of eyes. Rinse with water to remove

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 15–30 minutes before sun exposure and as needed.

■ Reapply after towel drying, swimming or sweating.

■ For children under six months of age, consult a physician.

Inactive Ingredients

Butylated Hydroxytoluene, Carbomer, Cetyl Alcohol, DEA-Cetyl Phosphate, Dexpanthenol, Dimethicone, Disodium Edetate, 4-Methylbenzilidene Camphor, Octyldodecyl Neopentanoate, Phenoxyethanol and Methyl paraben and Ethylparaben and Propylparaben and Butylparaben, Propylene Glycol, Sodium hydroxide, Stearic Acid, Triethanolamine, Vitamin E, Water/Eau.

Questions or Comments

450 455 9779 1 877 484 8437

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

SUNSCREEN
LOTION
SPF 30
ENRICHED WITH
ANTIOXIDANTS

Dist. by Vivier Pharma
Champlain NY USA 12919
vivierpharma.com
® Vivier Canada Inc.
– used under license

Made in Canada

Vivier Sunscreen SPF 30

Vivierskin Sunscreen Lotion

SUNSCREEN SPF 30
avobenzone, octinoxate, ensulizole lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67226-2030
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	55 mg in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	20 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
CETYL ALCOHOL (UNII: 936JST6JCN)
PANTOTHENIC ACID (UNII: 19F5HK2737)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67226-2030-6	1 in 1 BOX	03/15/2011	01/31/2017
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:67226-2030-1	1 in 1 BOX	01/01/2006	01/31/2017
2		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:67226-2030-5	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2007	01/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2006	01/31/2017

Labeler - Vivier Pharma, Inc. (250996550)

Revised: 1/2020

Document Id: 9d7235be-e358-0bb0-e053-2995a90a4801

Set id: 2b5860b0-6872-4124-af1e-c75e3adeff56

Version: 9

Effective Time: 20200131

Vivier Pharma, Inc.