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TENDER MOMENTS SPF 45

Dosage form: lotion
Ingredients: HOMOSALATE 10g in 100mL, OCTINOXATE 7.7g in 100mL, OCTISALATE 5g in 100mL, OCTOCRYLENE 1.5g in 100mL, TITANIUM DIOXIDE 5.5g in 100mL, OXYBENZONE 5g in 100mL
Labeler: JAFRA COSMETICS INTERNATIONAL
NDC Code: 68828-060

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.

TENDER MOMENTS SPF 45

SUNSCREEN ACTIVE INGREDIENT (SPF 45): TITANIUM DIOXIDE, OXYBENZONE/BENZOPHENONE-3, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE

PURPOSE: SUNSCREEN

OTHER INGREDIENTS: WATER/AQUA, ALUMINA, DIMETHICONE, SODIUM DIHYDROXYCETYL PHOSPHATE, GLYCERYL STEARATE SE, ADIPIC ACID/DIETHYLENE GLYCOL/GLYCERIN CROSSPOLYMER, PVP/EICOSENE COPOLYMER, AVENA SATIVA (OAT) KERNEL EXTRACT, PANTHENOL, TOCOPHERYL  ACETATE, BUTYLENE GLYCOL, CETYL ALCOHOL, XANTHAN GUM, FRAGRANCE/PARFUM, DMDM HYDANTOIN, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRISODIUM EDTA, [FRAGRANCE/PARFUM CONTAINS: CITRONELLOL, GERANIOL, HEXYL CINNAMAL, HYDROXYCITRONELLOL, BUTYLPHENYL METHYLPROPIONAL (LILLIAL), LINALOL, ALPHA-ISOMMETHYL IONONE]

BABY BLOCK SPF 45

APPLY WATER-RESISTANT SUNSCREEN 20 MINUTES BEFORE SUN EXPOSURE.

DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR.

KEEP OUT OF REACH OF CHILDREN.

TENDER MOMENTS
BABY BLOCK SPF 45

JAFRA



WARNINGS: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

SEEK THE ADVICE OF A PHYSICIAN PRIOR TO USE ON CHILDREN UNDER 6 MONTHS OF AGE.

TENDER MOMENTS  SPF 45
homosalate octinoxate octisalate oxybenzone titanium dioxide octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-060
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE10 g  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.7 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE1.5 g  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE5.5 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALUMINUM OXIDE 
DIMETHICONE 
GLYCERYL STEARATE SE 
SODIUM PHOSPHATE, MONOBASIC 
BUTYLENE GLYCOL 
DIETHYLENE GLYCOL ADIPATE 
OAT 
POVIDONE K30 
CETYL ALCOHOL 
PEG-4 LAURATE 
DMDM HYDANTOIN 
IODOPROPYNYL BUTYLCARBAMATE 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
XANTHAN GUM 
EDETATE TRISODIUM 
Packaging
#Item CodePackage Description
1NDC:68828-060-1350 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/24/2012
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIOperations
Jafra Manufacturing, S.A. de C.V.814732061manufacture

Revised: 05/2012
Document Id: 714465bd-2186-4e99-9fb7-4eb6c509b56e
Set id: 537296b2-3782-4081-98b2-483e8aaf8b6e
Version: 1
Effective Time: 20120516
 
JAFRA COSMETICS INTERNATIONAL

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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