LBEL- octinoxate, octisalate, oxybenzone, and titanium dioxide lotion

LBEL by

Drug Labeling and Warnings

LBEL by is a Otc medication manufactured, distributed, or labeled by Ventura International Ltd., BelStar, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 7.5%,
Octivsalate 5%,
Oxybenzone 6%,
Titanium dioxide 2.34%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.
• Provides moderate protection against sunburn.
• Retains SPF after 40 minutes of activity in the water

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 liberally before sun exposure and as needed

Other information

• Sun alert: Limiting sun exposure, waring protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Aqua (water), dicaprylyl carbonate, c12-15 alkyl benzoate, vp/eicosene copolymer, methyl methacrylate crosspolymer, cyclopentasiloxane, dimethicone, cetearyl alcohol, sorbitan stearate, cyclohexasiloxane, glyceryl stearate, potassium cetyl phosphate, tocopheryl acetate, trimethylsiloxysilicate, phenoxyethanol, silica, methicone, ceteareth-20, methylparaben, xanthan gum, mannitol, parfum (fragrance), propylparaben, butylparaben, ethylparaben, isobutylparaben, arginine, cyclodextrin, dextrin, faex extract (yeast extract), histidine hydrochloride (histidine hci), pisum sativum extract (pisum sativum (pea) extract), acetyl tyrosine, disodium succinate, khaya senegalensis bark extract, nicotinamide adenine dinucleotide, pyridoxine hci, aspartic acid

PRINCIPAL DISPLAY PANEL - 180 ml Bottle Carton

L'BEL

PROTÈGE
EXPERT

moisturizing body
protector lotion
SPF 15

WATER RESISTANT

180 ml e (6.3 fl.oz.)

UVB SPF
15
Moderate
Protection

UVA
PA ++

INGREDIENTS AND APPEARANCE

LBEL   PROTEGE EXPERT
octinoxate, octisalate, oxybenzone, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	.075 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	.05 g  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	.06 g  in 1 mL
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	.0234 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dicaprylyl carbonate (UNII: 609A3V1SUA)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
trolamine (UNII: 9O3K93S3TK)
cyclomethicone 5 (UNII: 0THT5PCI0R)
dimethicone (UNII: 92RU3N3Y1O)
cetostearyl alcohol (UNII: 2DMT128M1S)
sorbitan monostearate (UNII: NVZ4I0H58X)
cyclomethicone 6 (UNII: XHK3U310BA)
glyceryl monostearate (UNII: 230OU9XXE4)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
phenoxyethanol (UNII: HIE492ZZ3T)
silicon dioxide (UNII: ETJ7Z6XBU4)
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)
methylparaben (UNII: A2I8C7HI9T)
xanthan gum (UNII: TTV12P4NEE)
mannitol (UNII: 3OWL53L36A)
propylparaben (UNII: Z8IX2SC1OH)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
isobutylparaben (UNII: 0QQJ25X58G)
arginine (UNII: 94ZLA3W45F)
yeast (UNII: 3NY3SM6B8U)
histidine monohydrochloride (UNII: 1D5Q932XM6)
pea (UNII: W4X7H8GYFM)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
khaya senegalensis bark (UNII: 1S7EDA839L)
nadide (UNII: 0U46U6E8UK)
pyridoxine hydrochloride (UNII: 68Y4CF58BV)
aspartic acid (UNII: 30KYC7MIAI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-301-02	1 in 1 BOX
1	NDC: 14783-301-01	180 mL in 1 BOTTLE
2	NDC: 14783-301-04	1 in 1 BOX
2	NDC: 14783-301-03	10 mL in 1 TUBE
3	NDC: 14783-301-06	1 in 1 BOX
3	NDC: 14783-301-05	5 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/19/2011

Labeler - Ventura International Ltd. (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
BelStar, S.A.		880160197	MANUFACTURE