BELLAGIO SUNSCREEN FOR FACE SPF 30- octinoxate, octocrylene, octisalate, and zinc oxide lotion

Bellagio Sunscreen For Face SPF 30 by

Drug Labeling and Warnings

Bellagio Sunscreen For Face SPF 30 by is a Otc medication manufactured, distributed, or labeled by Lifetech Resources, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

Octinoxate 7.50%, Octocrylene 6.00%, Octisalate 5.00%, Zinc Oxide 2.94%

PURPOSE

Sunscreen

USE

Helps prevent sunburn. Higher SPF gives more sunburn protection.

DIRECTIONS FOR USE

Apply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Reapply as needed or after swimming, towel drying, perspiring, or vigorous activity. Ask a doctor before use on children under 6 months of age.

WARNING

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.

INACTIVE INGREDIENTS

Water, Ethylhexyl Isononanoate, Acrylates Copolymer, Butylene Glycol, Cetyl Alcohol, PEG-100 Stearate, Sorbitan Stearate, Polysorbate-60, Glyceryl Stearate, Dimethicone, Squalane, Hydroxylated Lecithin, Xanthan Gum, Allantoin, Tocopheryl Acetate, Centella Asiatica Extract, Echinacea Angustifolia Extract, Vitis Vinifera (Grape) Seed Extract, Citrus Medica Limonum (Lemon) Peel Extract, Melissa Officinalis Extract, Citric Acid, Triethoxycaprylylsilane, Imidazolidinyl Urea, Sodium Benzoate, Disodium EDTA, Potassium Sorbate.

PRINCIPAL DISPLAY PANEL - 118 ML Tube Label

BELLAGIO®
SUNSCREEN
LOTION FOR FACE
SPF 30

4 FL OZ / 118 ML

INGREDIENTS AND APPEARANCE

BELLAGIO SUNSCREEN FOR FACE SPF 30 
octinoxate, octocrylene, octisalate, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65643-325
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	74.25 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	59.4 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	49.5 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	29.106 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Cetyl Alcohol (UNII: 936JST6JCN)
Polyoxyl 100 Stearate (UNII: YD01N1999R)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Polysorbate 60 (UNII: CAL22UVI4M)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Dimethicone (UNII: 92RU3N3Y1O)
Squalane (UNII: GW89575KF9)
Xanthan Gum (UNII: TTV12P4NEE)
Allantoin (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
Lemon Peel (UNII: 72O054U628)
MELISSA OFFICINALIS (UNII: YF70189L0N)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Imidurea (UNII: M629807ATL)
Sodium Benzoate (UNII: OJ245FE5EU)
Edetate Disodium (UNII: 7FLD91C86K)
Potassium Sorbate (UNII: 1VPU26JZZ4)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65643-325-14	118 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2009

Labeler - Lifetech Resources, LLC (622559110)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC		622559110	MANUFACTURE