LBEL- octinoxate, octisalate, and oxybenzone lotion

LBEL by

Drug Labeling and Warnings

LBEL by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation Ltd. (San Juan, P.R), Bel Star, S.A., Yobel Supply Chain Management S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
Octinoxate 7.5%	Sunscreen
Octisalate 4.0 %	Sunscreen
Oxybenzone 4.0%,	Sunscreen

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection
• Provides moderate protection against sunburn

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 smoothly every morning before sun exposure and as needed.
• Use in the morning after cleansing and toning. Apply small amounts using the fingertips and spreading with upward, circular movements. Rub gently until absorbed completely.
• Children under 6 months of age: ask a doctor.
• Moderate sun protection product

Other information

• Sun alert: Limiting sun exposure, wearing 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), c12-15 alkyl benzoate, pisum sativum extract (pisum sativum (pea) extract), cyclohexasiloxane, dimethicone, butylene glycol, cetearyl alcohol, erythritol, hdi/trimethylol hexyllactone crosspolymer, phenoxyethanol, sodium acrylate/ acryloyldimethyltaurate/ dimethylacrylamide crosspolymer, c20-22 alkyl phosphate, glyceryl stearate, hydroxyethyl acrylate/ sodium acryloyldimethyl taurate copolymer, propylene glycol, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, parfum (fragrance), c14-22 alcohols, cetearyl glucoside, butylparaben, cyclopentasiloxane, chlorphenesin, xanthan gum, propylparaben, acrylates/ c10-30 alkyl acrylate crosspolymer, disodium edta, sorbic acid, polysorbate 60, c12-20 alkyl glucoside, glycerin, hydrolyzed algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, homarine hcl, rubus chamaemorus fruit extract

SPL UNCLASSIFIED SECTION

P.R.: Dist by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

L'BEL

HYDRA CALME

SPF15
Intensive moisturizing
face lotion with SPF 15

50 ml e (1.6 fl.oz.)

INGREDIENTS AND APPEARANCE

LBEL   HYDRA CALME SPF 15
octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.04 g  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.04 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
pea (UNII: W4X7H8GYFM)
cyclomethicone 6 (UNII: XHK3U310BA)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
cetostearyl alcohol (UNII: 2DMT128M1S)
erythritol (UNII: RA96B954X6)
phenoxyethanol (UNII: HIE492ZZ3T)
c20-22 alkyl phosphate (UNII: L4VKP0Y7RP)
glyceryl monostearate (UNII: 230OU9XXE4)
propylene glycol (UNII: 6DC9Q167V3)
c20-22 alcohols (UNII: O4M0347C6A)
trolamine (UNII: 9O3K93S3TK)
isohexadecane (UNII: 918X1OUF1E)
methylparaben (UNII: A2I8C7HI9T)
c14-22 alcohols (UNII: B1K89384RJ)
cetearyl glucoside (UNII: 09FUA47KNA)
butylparaben (UNII: 3QPI1U3FV8)
cyclomethicone 5 (UNII: 0THT5PCI0R)
chlorphenesin (UNII: I670DAL4SZ)
xanthan gum (UNII: TTV12P4NEE)
propylparaben (UNII: Z8IX2SC1OH)
edetate disodium (UNII: 7FLD91C86K)
sorbic acid (UNII: X045WJ989B)
polysorbate 60 (UNII: CAL22UVI4M)
c12-20 alkyl glucoside (UNII: K67N5Z1RUA)
glycerin (UNII: PDC6A3C0OX)
ethylparaben (UNII: 14255EXE39)
chlorella vulgaris (UNII: RYQ4R60M02)
isobutylparaben (UNII: 0QQJ25X58G)
silicon dioxide (UNII: ETJ7Z6XBU4)
rubus chamaemorus fruit (UNII: 74CW8G72Q6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-031-02	1 in 1 BOX
1	NDC: 13537-031-01	50 mL in 1 TUBE
2	NDC: 13537-031-04	1 in 1 BOX
2	NDC: 13537-031-03	5 mL in 1 TUBE
3	NDC: 13537-031-05	1 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/29/2011

Labeler - Ventura Corporation Ltd. (San Juan, P.R) (602751344)

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

Establishment
Name	Address	ID/FEI	Business Operations
Yobel Supply Chain Management S.A.		934116930	MANUFACTURE