L'bel Hydra Calme Spf 15 Intensive Moisturizing Facial Lotion

L'bel Hydra Calme Spf 15 Intensive Moisturizing Facial Lotion
SPL v1
SPL
SPL Set ID 7c57c221-522e-4874-9f56-31d8ae043f2f
Route
TOPICAL
Published
Effective Date 2012-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 mL) Octisalate (4 mL) Oxybenzone
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Pea Cyclomethicone 6 Dimethicone Butylene Glycol Cetostearyl Alcohol Erythritol Phenoxyethanol Sodium Acrylate C20-22 Alkyl Phosphate Glyceryl Monostearate Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Propylene Glycol C20-22 Alcohols Trolamine Isohexadecane Methylparaben C14-22 Alcohols Cetearyl Glucoside Butylparaben Cyclomethicone 5 Xanthan Gum Propylparaben Edetate Disodium Sorbic Acid Polysorbate 60 C12-20 Alkyl Glucoside Glycerin Ethylparaben Chlorella Vulgaris Isobutylparaben Silicon Dioxide Homarine Hydrochloride Rubus Chamaemorus Fruit

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-03-25

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

Uses
  • Helps prevent sunburn

Section 50567-7

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

US: Dist. by Ventural Internationa Ltd.  DBA Bellcorp USA, San Francisco, CA 94111



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

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.
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.

Do Not Use

on damaged or broken skin.

Other Information

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.

Active Ingredients

Octinoxate  (7.5%),

Octisalate  (4%),

Oxybenzone (4%)

Expert Routine L'bel

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

  • Cleanse the skin according to its needs
  • 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



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.

L'bel Hydra Calme Spf 15 Intensive Moisturizing Facial Lotion




Structured Label Content

Uses
  • Helps prevent sunburn

Section 50567-7 (50567-7)

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

US: Dist. by Ventural Internationa Ltd.  DBA Bellcorp USA, San Francisco, CA 94111



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

Purpose

Sunscreen

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.
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.

Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)

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.

Active Ingredients

Octinoxate  (7.5%),

Octisalate  (4%),

Oxybenzone (4%)

Expert Routine L'bel (EXPERT ROUTINE L'BEL)

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

  • Cleanse the skin according to its needs
  • 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



When Using This Product (When using this product)

keep out of eyes.  Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

L'bel Hydra Calme Spf 15 Intensive Moisturizing Facial Lotion (L'BEL HYDRA CALME SPF 15 Intensive Moisturizing Facial Lotion)




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