Label: LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL- octinoxate, octisalate, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 43596-0002-0, 43596-0002-1, 43596-0002-2, 43596-0002-3 - Packager: Ventura Corporation, LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 25, 2012
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- Official Label (Printer Friendly)
- L'BEL HYDRA CALME SPF 15 Intensive Moisturizing Facial Lotion
- Active Ingredients
- Uses
- Warnings
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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
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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
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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.
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
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 SPF 15 Intensive Moisturizing Facial Lotion
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INGREDIENTS AND APPEARANCE
LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL
octinoxate, octisalate, oxybenzone lotionProduct 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