LBEL PARIS- octinoxate, octocrylene, and oxybenzone cream

LBel Paris by

Drug Labeling and Warnings

LBel Paris 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 %), Octocrylene (5 %), Oxybenzone (3 %)

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.
• Children under 6 months of age: ask a doctor.

Other information

• Moderate sun protection product.
• 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), cyclohexasiloxane, soy protein phthalate, glycerin, pisum sativum (pea) extract, c12-15 alkyl benzoate, caprylic / capric triglyceride, cyclopentasiloxane, cetyl alcohol, cetearyl alcohol, isopropyl myristate, isononyl isononanoate, sorbitan stearate, mannitol, glyceryl stearate, potassium cetyl phosphate, dimethicone / vinyl dimethicone crosspolymer, dimethicone crosspolymer, triethanolamine, acrylates / c10-30 alkyl acrylate crosspolymer, ceteareth-20, propylparaben, panthenol, sodium pca, steareth-20, ceteth-20, parfum (fragance), ci 77891 (titanium dioxide), chlorphenesin, dimethiconol, teprenone, ppg-26-buteth-26, polysorbate 80, peg-40 hydrogenated castor oil, tetrasodium edta, cyclodextrin, butylene glycol, hydrolyzed algin, hedera helix (ivy) leaf / stem extract, faex extract (yeast extract), magnesium pca, chlorella vulgaris extract, maris aqua (sea water), algin, tocopheryl acetate, zinc pca, retinyl palmitate, saccharomyces / magnesium ferment, ascorbyl palmitate, serine, urea, acacia, senegal gum, bioflavonoids, allantoin, disodium succinate, saccharomyces /iron ferment, manganese pca, saccharomyces /copper ferment, saccharomyces /calcium ferment, saccharomyces /silicon ferment, saccharomyces /zinc ferment.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

L'BEL

RENOVÂNCE JOUR

intensive refining, fortifying and renewing treatment
spf 15 daytime face and neck cream

50 g e (1.7 oz.)

INGREDIENTS AND APPEARANCE

LBEL PARIS   RENOVANCE JOUR
octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.75 g  in 50 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	2.5 g  in 50 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	1.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 6 (UNII: XHK3U310BA)
glycerin (UNII: PDC6A3C0OX)
snow pea (UNII: 84SKC33B1I)
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)
medium-chain triglycerides (UNII: C9H2L21V7U)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cetyl alcohol (UNII: 936JST6JCN)
cetostearyl alcohol (UNII: 2DMT128M1S)
isopropyl myristate (UNII: 0RE8K4LNJS)
isononyl isononanoate (UNII: S4V5BS6GCX)
sorbitan monostearate (UNII: NVZ4I0H58X)
mannitol (UNII: 3OWL53L36A)
glyceryl monostearate (UNII: 230OU9XXE4)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
trolamine (UNII: 9O3K93S3TK)
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)
propylparaben (UNII: Z8IX2SC1OH)
panthenol (UNII: WV9CM0O67Z)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
steareth-20 (UNII: L0Q8IK9E08)
ceteth-20 (UNII: I835H2IHHX)
chlorphenesin (UNII: I670DAL4SZ)
titanium dioxide (UNII: 15FIX9V2JP)
teprenone (UNII: S8S8451A4O)
polysorbate 80 (UNII: 6OZP39ZG8H)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
edetate sodium (UNII: MP1J8420LU)
butylene glycol (UNII: 3XUS85K0RA)
kalmia latifolia leaf (UNII: 79N6542N18)
yeast (UNII: 3NY3SM6B8U)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
serine (UNII: 452VLY9402)
urea (UNII: 8W8T17847W)
acacia (UNII: 5C5403N26O)
allantoin (UNII: 344S277G0Z)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-038-61	1 in 1 BOX
1	NDC: 14783-038-62	50 g 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

LBEL PARIS   RENOVANCE JOUR
octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.375 g  in 5 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.25 g  in 5 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.15 g  in 5 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 6 (UNII: XHK3U310BA)
glycerin (UNII: PDC6A3C0OX)
snow pea (UNII: 84SKC33B1I)
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)
medium-chain triglycerides (UNII: C9H2L21V7U)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cetyl alcohol (UNII: 936JST6JCN)
cetostearyl alcohol (UNII: 2DMT128M1S)
isopropyl myristate (UNII: 0RE8K4LNJS)
isononyl isononanoate (UNII: S4V5BS6GCX)
sorbitan monostearate (UNII: NVZ4I0H58X)
mannitol (UNII: 3OWL53L36A)
glyceryl monostearate (UNII: 230OU9XXE4)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
trolamine (UNII: 9O3K93S3TK)
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)
propylparaben (UNII: Z8IX2SC1OH)
panthenol (UNII: WV9CM0O67Z)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
steareth-20 (UNII: L0Q8IK9E08)
ceteth-20 (UNII: I835H2IHHX)
chlorphenesin (UNII: I670DAL4SZ)
titanium dioxide (UNII: 15FIX9V2JP)
teprenone (UNII: S8S8451A4O)
polysorbate 80 (UNII: 6OZP39ZG8H)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
edetate sodium (UNII: MP1J8420LU)
butylene glycol (UNII: 3XUS85K0RA)
kalmia latifolia leaf (UNII: 79N6542N18)
yeast (UNII: 3NY3SM6B8U)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
serine (UNII: 452VLY9402)
urea (UNII: 8W8T17847W)
acacia (UNII: 5C5403N26O)
allantoin (UNII: 344S277G0Z)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-028-51	1 in 1 BOX
1	NDC: 14783-028-52	5 g 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

LBEL PARIS   RENOVANCE JOUR
octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-018
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 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.05 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 6 (UNII: XHK3U310BA)
glycerin (UNII: PDC6A3C0OX)
snow pea (UNII: 84SKC33B1I)
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)
medium-chain triglycerides (UNII: C9H2L21V7U)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cetyl alcohol (UNII: 936JST6JCN)
cetostearyl alcohol (UNII: 2DMT128M1S)
isopropyl myristate (UNII: 0RE8K4LNJS)
isononyl isononanoate (UNII: S4V5BS6GCX)
sorbitan monostearate (UNII: NVZ4I0H58X)
mannitol (UNII: 3OWL53L36A)
glyceryl monostearate (UNII: 230OU9XXE4)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
trolamine (UNII: 9O3K93S3TK)
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)
propylparaben (UNII: Z8IX2SC1OH)
panthenol (UNII: WV9CM0O67Z)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
steareth-20 (UNII: L0Q8IK9E08)
ceteth-20 (UNII: I835H2IHHX)
chlorphenesin (UNII: I670DAL4SZ)
titanium dioxide (UNII: 15FIX9V2JP)
teprenone (UNII: S8S8451A4O)
polysorbate 80 (UNII: 6OZP39ZG8H)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
edetate sodium (UNII: MP1J8420LU)
butylene glycol (UNII: 3XUS85K0RA)
kalmia latifolia leaf (UNII: 79N6542N18)
yeast (UNII: 3NY3SM6B8U)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
serine (UNII: 452VLY9402)
urea (UNII: 8W8T17847W)
acacia (UNII: 5C5403N26O)
allantoin (UNII: 344S277G0Z)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-018-41	1 in 1 BOX
1	NDC: 14783-018-42	1 g 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 (603192787)