LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL- octinoxate, octisalate, oxybenzone lotion

LBEL HYDRA CALME SPF 15 Intensive Moisturizing Facial by

Drug Labeling and Warnings

LBEL HYDRA CALME SPF 15 Intensive Moisturizing Facial by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation, LTD, MF Productions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

L'BEL HYDRA CALME SPF 15 Intensive Moisturizing Facial Lotion

Active Ingredients

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

Uses

• Helps prevent sunburn
  

Warnings

• Skin Cancer / Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
• 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

• 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.
• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 years
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age:  Ask a doctor.
  

Other information

Protect the product in this container from excessive heat and direct 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 / acryloyldimethyl-taurate / 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/c10-20 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.

Purpose

Sunscreen

EXPERT ROUTINE L'BEL

L'Bel presents Expert Routine, a skin care program with two steps that work together for enhanced results:

1. Cleanse the skin according to its needs
2. Nourish according to the age.

HYDRA CALME
Intensive moisturizing line

To help protect the skin against dehydration, tightness, roughness, dullness and loss of vitality.  L'Bel presents the Hydra Calme Intensive Moisturizing Line.  A miracle of maximum moisturization and comfort for all ages and skin types.

A new skin care concept whose extraordinary revitalizing and comforting action inundates the skin with a pleasant feeling of freshness, softness and wellbeing to protect it and recover its appearance of beauty and youthfulness.

The fountain of youth the skin needs every day
Hydra Calm Intensive Moisturizing Line offers immediate and prolonged moisturization to the areas of the face that need it most.  Its exclusive formulas reestablish the skin's hydric balance and facilitate the transportation of water according to the skin's moisturization needs.

A discover that changed the concept of moisturization
An innovative discovery in the world of cosmetic technology: Hydra Comfort Systeme.  A powerful moisturizing complex based on Arctic Berry Extract, an exceptional source of carbohydrates, vitamins, minerals and antioxidants with comforting and softening properties.

Two formulas for all ages and skin types,  both with a soft, comforting texture and rapid absorption properties:

1. Intensive moisturizing facial lotion SPF 15

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 fingertips and spreading with upward circular movements.  Rub gently until absorbed completed.  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.
• HYPOALLERGENIC
• DERMATOLOGICALLY TESTED

2.  Intensive moisturizing facial cream gel

USE:  Use in the morning and / or at night after cleansing and toning.  Apply small amounts using the fingertips and spreading with upward, circular movements.  Rub gently until absorbed completely.

WARNING:  For external use only.  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.

•  HYPOALLERGENIC
• DERMATOLOGICALLY TESTED
  

PRINCIPAL DISPLAY PANEL

L'BEL  HYDRA CALME FPS 15  intensive moisturizing facial lotion SPF 15  50 ml e (1.6 fl.oz.)

US: Dist. by Ventura International Ltd.  DBA Belcorp USA, San Francisco, CA 94111

P.R. Dist. by Ventura Corporation Ltd., San Juan, Puerto Rico 00926  MADE IN FRANCE

L'BEL HYDRA CALME SPF 15 Intensive Moisturizing Facial Lotion

INGREDIENTS AND APPEARANCE

LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL 
octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 mL  in 100 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)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
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)
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)
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
RUBUS CHAMAEMORUS FRUIT (UNII: 74CW8G72Q6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0002-0	1 mL in 1 POUCH
2	NDC: 43596-0002-1	3 mL in 1 TUBE
3	NDC: 43596-0002-2	30 mL in 1 JAR
4	NDC: 43596-0002-3	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/25/2012

Labeler - Ventura Corporation, LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
MF Productions		266769145	manufacture