BELLAGIO CHILDRENS SUNSCREEN SPF 45- homosalate, octinoxate, octisalate, oxybenzone, and zinc oxide lotion

Bellagio Childrens Sunscreen SPF 45 by

Drug Labeling and Warnings

Bellagio Childrens Sunscreen SPF 45 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

Homosalate 14.00%, Octinoxate 6.50%, Octisalate 5.00%, Oxybenzone 5.00%, Zinc Oxide 2.74%

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, Caprylic/Capric Triglyceride, Acrylates Copolymer, Cyclopentasiloxane, Polysorbate 60, Cetearyl Alcohol, Ceteareth-20, Glycerin, Potassium Cetyl Phosphate, Sorbitan Stearate, VP/Hexadecene Copolymer, Polysorbate 20, Dimethicone, Butyrospermum Parkii (Shea Butter), Squalane, Panthenol, Sodium PCA, Tocopheryl Acetate, Persea Gratissima (Avocado) Oil, Macadamia Ternifolia Seed Oil, Aloe Barbadensis Leaf Extract, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Xanthan Gum, Triethoxycaprylylsilane, Disodium EDTA, Imidazolidinyl Urea, Sodium Benzoate, Potassium Sorbate.

PRINCIPAL DISPLAY PANEL - 118 ML Tube Label

BELLAGIO®
CHILDREN'S
SUNSCREEN
LOTION
SPF 45

4 FL OZ / 118 ML

INGREDIENTS AND APPEARANCE

BELLAGIO CHILDRENS SUNSCREEN SPF 45 
homosalate, octinoxate, octisalate, oxybenzone, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65643-336
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	141.904 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	65.884 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50.68 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50.68 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	27.773 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Glycerin (UNII: PDC6A3C0OX)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Polysorbate 60 (UNII: CAL22UVI4M)
Polysorbate 20 (UNII: 7T1F30V5YH)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Dimethicone (UNII: 92RU3N3Y1O)
Shea Butter (UNII: K49155WL9Y)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Panthenol (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Avocado (UNII: SDS87L369F)
Macadamia Oil (UNII: 515610SU8C)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
Xanthan Gum (UNII: TTV12P4NEE)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Benzoate (UNII: OJ245FE5EU)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Imidurea (UNII: M629807ATL)
OCTYLTRIETHOXYSILANE (UNII: LDC331P08E)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65643-336-19	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	02/01/2009

Labeler - Lifetech Resources, LLC (622559110)

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