FDA Label for Lbel Hydra Calme Spf 15

View Indications, Usage & Precautions

Lbel Hydra Calme Spf 15 Product Label

The following document was submitted to the FDA by the labeler of this product Ventura International Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

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


Otc - Purpose



Active IngredientPurpose
Octinoxate 7.5%Sunscreen
Octisalate 4.0 %Sunscreen
Oxybenzone 4.0%,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 or irritation develops and lasts

Otc - 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.


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 sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the 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/ acryloyldimethyltaurate/ 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/ c10-30 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


Principal Display Panel - 50 Ml Bottle Carton



L'BEL

HYDRA CALME

SPF 15
intensive moisturizing
face lotion with SPF 15

50 ml e (1.6 fl.oz.)


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