LBEL- octinoxate, octisalate, and oxybenzone lotion

LBEL by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate (7.5%), Octisalate (4%), Oxybenzone (4 %)

Purpose

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 and 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 sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.

Inactive ingredients

Aqua (water), c12-15 alkyl benzoate, 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, propyleneglycol, hydroxyethyl acrylate/sodium acryloyldymethyl taurate copolymer, glyceryl stearate, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, parfum (fragance), c14-22 alcohols, cetearyl glucoside, butylparaben, cyclopentasiloxane, chlorphenesin, propylparaben, xanthan gum, disodium edta, acrylates/c10-30 alkylacrilate crosspolymer, sorbic acid, polysorbate 60, c12-20 alkyl glucoside, glycerin, hydrolized algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, homarine hcl, rubus chamaemorus fruit extract.

SPL UNCLASSIFIED SECTION

USA: Distributed by Ventura
International Ltd, San Francisco,
CA 94111.

PRINCIPAL DISPLAY PANEL - 30 ml Carton

L'BEL
PARIS

HYDRA CALME

SPF 15

intensive moisturizing facial
lotion SPF 15

30 ml e (1 fl.oz.)

INGREDIENTS AND APPEARANCE

LBEL   HYDRA CALME
octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-088
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	2.25 mg  in 30 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	1.2 mg  in 30 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	1.2 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)
snow pea (UNII: 84SKC33B1I)
cyclomethicone 6 (UNII: XHK3U310BA)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
cetostearyl alcohol (UNII: 2DMT128M1S)
erythritol (UNII: RA96B954X6)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene glycol (UNII: 6DC9Q167V3)
glyceryl monostearate (UNII: 230OU9XXE4)
trolamine (UNII: 9O3K93S3TK)
isohexadecane (UNII: 918X1OUF1E)
methylparaben (UNII: A2I8C7HI9T)
butylparaben (UNII: 3QPI1U3FV8)
cyclomethicone 5 (UNII: 0THT5PCI0R)
chlorphenesin (UNII: I670DAL4SZ)
propylparaben (UNII: Z8IX2SC1OH)
xanthan gum (UNII: TTV12P4NEE)
edetate disodium (UNII: 7FLD91C86K)
sorbic acid (UNII: X045WJ989B)
polysorbate 60 (UNII: CAL22UVI4M)
glycerin (UNII: PDC6A3C0OX)
ethylparaben (UNII: 14255EXE39)
isobutylparaben (UNII: 0QQJ25X58G)
silicon dioxide (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-088-63	1 in 1 BOX
1	NDC: 13537-088-62	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/15/2010

LBEL   HYDRA CALME
octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-089
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)
snow pea (UNII: 84SKC33B1I)
cyclomethicone 6 (UNII: XHK3U310BA)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
cetostearyl alcohol (UNII: 2DMT128M1S)
erythritol (UNII: RA96B954X6)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene glycol (UNII: 6DC9Q167V3)
glyceryl monostearate (UNII: 230OU9XXE4)
trolamine (UNII: 9O3K93S3TK)
isohexadecane (UNII: 918X1OUF1E)
methylparaben (UNII: A2I8C7HI9T)
butylparaben (UNII: 3QPI1U3FV8)
cyclomethicone 5 (UNII: 0THT5PCI0R)
chlorphenesin (UNII: I670DAL4SZ)
propylparaben (UNII: Z8IX2SC1OH)
xanthan gum (UNII: TTV12P4NEE)
edetate disodium (UNII: 7FLD91C86K)
sorbic acid (UNII: X045WJ989B)
polysorbate 60 (UNII: CAL22UVI4M)
glycerin (UNII: PDC6A3C0OX)
ethylparaben (UNII: 14255EXE39)
isobutylparaben (UNII: 0QQJ25X58G)
silicon dioxide (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-089-53	1 in 1 BOX
1	NDC: 13537-089-52	1 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/15/2010

Labeler - Ventura International LTD (602751344)