LBEL DEFENSE TOTAL COMPACT SUNCREEN SPF 50 FOR FACE - MATTE FINISH- octinoxate, octocrylene, and zinc oxide cream

LBEL Defense Total Compact Suncreen SPF 50 For Face - Matte Finish by

Drug Labeling and Warnings

LBEL Defense Total Compact Suncreen SPF 50 For Face - Matte Finish 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
OCTINOXATE 7%	Sunscreen
OCTOCRYLENE 5%	Sunscreen
ZINC OXIDE 16.66%	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

DIMETHICONE, ZEA MAYS (CORN) STARCH, POLYMETHYLSILSESQUIOXANE, POLYETHYLENE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, MICA, OZOKERITE, BUTYROSPERMUM PARKII (SHEA) BUTTER, SORBITAN SESQUIOLEATE, PEG/PPG-18/18 DIMETHICONE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, DIISOPROPYL ADIPATE, COPERNICIA CERIFERA (CARNAUBA) WAX, TOCOPHERYL ACETATE, CERAMIDE 3, CAPRYLYL GLYCOL, CHLORPHENESIN, PHYSALIS ANGULATA EXTRACT, FRAGRANCE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SILICA, TRIMETHYLSILOXYSILICATE, OXOTHIAZOLIDINE, LINALOOL.

MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 9,5 g Container Box

MEDIUM

L'BEL
DÉFENSETOTAL

HIGH PROTECTION
SPF
50

compact cream sunscreen
for face - matte finish

BROAD SPECTRUM
WATER RESISTANT (40 minutes)

Net Wt. 0.34 oz. e (9,5 g)

INGREDIENTS AND APPEARANCE

LBEL DEFENSE TOTAL COMPACT SUNCREEN SPF 50 FOR FACE - MATTE FINISH 
octinoxate, octocrylene, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0062
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.05 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.1666 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, CORN (UNII: O8232NY3SJ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
SHEA BUTTER (UNII: K49155WL9Y)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
CARNAUBA WAX (UNII: R12CBM0EIZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
OXOTHIAZOLIDINE (UNII: M6U1ZG59XD)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0062-2	1 in 1 BOX	04/18/2017
1	NDC: 43596-0062-1	9.5 g in 1 CONTAINER; 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	04/18/2017

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(43596-0062)