LBEL  HYDRA CALME SPF 15- octinoxate, octisalate, and oxybenzone lotion 
Ventura Corporation Ltd. (San Juan, P.R)

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.

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L'BEL
HYDRA CALME

Drug Facts

Active IngredientPurpose
Octinoxate 7.5% Sunscreen
Octisalate 4.0 %Sunscreen
Oxybenzone 4.0%, Sunscreen

Uses

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

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

P.R.: Dist by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

L'BEL

HYDRA CALME

SPF15
Intensive moisturizing
face lotion with SPF 15

50 ml e (1.6 fl.oz.)

Principal Display Panel - 50 ml Bottle Carton
LBEL   HYDRA CALME SPF 15
octinoxate, octisalate, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.04 g  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.04 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
c20-22 alkyl phosphate (UNII: L4VKP0Y7RP)  
glyceryl monostearate (UNII: 230OU9XXE4)  
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)  
chlorphenesin (UNII: I670DAL4SZ)  
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)  
rubus chamaemorus fruit (UNII: 74CW8G72Q6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-031-021 in 1 BOX
1NDC:13537-031-0150 mL in 1 TUBE
2NDC:13537-031-041 in 1 BOX
2NDC:13537-031-035 mL in 1 TUBE
3NDC:13537-031-051 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/29/2011
Labeler - Ventura Corporation Ltd. (San Juan, P.R) (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star, S.A.880160197MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Yobel Supply Chain Management S.A.934116930MANUFACTURE

Revised: 9/2011
Document Id: 517068e5-4daf-4657-8f88-bd145e6010e0
Set id: 25cb3da7-9cf6-4031-9d4e-a4c710254859
Version: 1
Effective Time: 20110906
 
Ventura Corporation Ltd. (San Juan, P.R)