LBEL DEFENSE TOTAL BROAD SPECTRUM SPF 50PLUS SUNSCREEN FOR FACE AND BODY- avobenzone, homosalate, and octocrylene lotion

LBEL Defense Total broad spectrum SPF 50plus sunscreen for face and body by

Drug Labeling and Warnings

LBEL Defense Total broad spectrum SPF 50plus sunscreen for face and body by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
AVOBENZONE (3.00%)	Sunscreen
HOMOSALATE (10.00%)	Sunscreen
OCTOCRYLENE (8.00%)	Sunscreen

Uses

• Helps prevent sunburn.
• 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.

Warnings

• For external use only.

• Do not use on damaged or broken skin.

• When using this product keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• Children under 6 months of age: Ask a doctor
• 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.–2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.

Other information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

WATER, BUTYLOCTYL SALICYLATE, DIMETHICONE, POTASSIUM CETYL PHOSPHATE, POLYMETHYLSILSESQUIOXANE, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, ETHYLHEXYL METHOXYCRYLENE, PHENETHYL BENZOATE, PROPYLENE GLYCOL, VP/EICOSENE COPOLYMER, SILICA, TRIMETHYLSILOXYSILICATE, PHENOXYETHANOL, CETYL PALMITATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, FRAGRANCE, PHYSALIS ANGULATA EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, XANTHAN GUM, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL GLYCOL, DISODIUM EDTA, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, CITRIC ACID, OXOTHIAZOLIDINE.

SPL UNCLASSIFIED SECTION

PUERTO RICO: Dist. by Ventura Corp, Ltd.,
San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 10 ml Tube Box

L'BEL

DÉFENSE
TOTAL

HIGH PROTECTION
SPF
50+

broad spectrum
sunscreen
lotion for face
and body

WITH COLLAGEN
BIO-PROTECTORS

WATER RESISTANT
(40 minutes)

10 ml e (.33 fl.oz.)

INGREDIENTS AND APPEARANCE

LBEL DEFENSE TOTAL BROAD SPECTRUM SPF 50PLUS SUNSCREEN FOR FACE AND BODY 
avobenzone, homosalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-383
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.1 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.08 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
PHENETHYL BENZOATE (UNII: 0C143929GK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
OXOTHIAZOLIDINE (UNII: M6U1ZG59XD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-383-01	80 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 13537-383-03	1 in 1 BOX
2	NDC: 13537-383-02	10 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 13537-383-05	1 in 1 PACKAGE
3	NDC: 13537-383-04	1 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/22/2015

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-383)