CLARINS BROAD SPECTRUM SPF 15 SUNSCREEN DELECTABLE SELF TANNING MOUSSE

Dosage form: cream
Ingredients: AVOBENZONE 25mg in 1mL, OCTISALATE 50mg in 1mL, OCTINOXATE 75mg in 1mL, OCTOCRYLENE 20mg in 1mL
Labeler: Laboratoires Clarins S.A.
NDC Code: 58668-4281

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.

CLARINS BROAD SPECTRUM SPF 15 SUNSCREEN – DELECTABLE SELF TANNING MOUSSE

CLARINS BROAD SPECTRUM SPF 15 SUNSCREEN – DELECTABLE SELF TANNING MOUSSE


Active ingredients

AVOBENZONE 2.5%
OCTISALATE 5%
OCTINOXATE 7.5%
OCTOCRYLENE 2%

Purpose

Sunscreen

Uses:
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

For external use only.

Do not use

on damaged or broken skin.

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 product is swallowed, get me dical help or contact a Poison Control Center right away.

Directions:
  • apply liberally 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • children under 6 months: Ask a doctor
  • Sun Protection Measures. Spending time in the sun in creases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • reapply at least every 2 hours
  • use a water resistant sun screen if swimming or sweating

Other information:
  • protect this product from excessive heat and direct sun

Questions or comments?

Call 1-866-252-7467 Monday-Friday, 8 a.m. to 5 p.m.

Inactive ingredients

AQUA/WATER/EAU . ISONONYL ISONONANOATE . BUTYLENE GLYCOL . DIHYDROXYACETONE . CETEARYL ALCOHOL . ALOE BARBADENSIS LEAF JUICE . CETEARYL GLUCOSIDE . CETEARETH-20 . DIMETHICONE . ERYTHRULOSE . PARFUM/FRAGRANCE . PRUNUS INSITITIA SEED OIL . HYDROXY ETHYL ACRYLATE / SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER . MANNAN . XANTHAN GUM . ISOHEXADECANE . TOCOPHERYL ACETATE . DISODIUM EDTA . SORBIC ACID . POLYSORBATE 60 . PRUNUS AMYGDALUS AMARA (BITTER ALMOND) KERNEL OIL . SORBITAN ISOSTEARATE . TOCOPHEROL . PHENOXY ETHANOL . CARTHAMUS TINCTORIUS (SAFFLOWER) SEED CAKE EXTRACT . BHT . HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . CITRIC ACID . POTASSIUM SORBATE . SODIUM BENZOATE. [S1962A]

CLARINS BROAD SPECTRUM SPF 15 SUNSCREEN – DELECTABLE SELF TANNING MOUSSE 125ml (58668-4281-1)

CLARINS BROAD SPECTRUM SPF 15 SUNSCREEN DELECTABLE SELF TANNING MOUSSE 
avobenzone, octisalate, octinoxate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-4281
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE25 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE50 mg  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISONONYL ISONONANOATE 
BUTYLENE GLYCOL 
DIHYDROXYACETONE 
CETOSTEARYL ALCOHOL 
ALOE VERA LEAF 
CETEARYL GLUCOSIDE 
POLYOXYL 20 CETOSTEARYL ETHER 
DIMETHICONE 
PRUNUS DOMESTICA SUBSP. INSITITIA SEED OIL 
YEAST MANNAN 
XANTHAN GUM 
ISOHEXADECANE 
.ALPHA.-TOCOPHEROL ACETATE 
EDETATE DISODIUM 
SORBIC ACID 
POLYSORBATE 60 
BITTER ALMOND OIL 
SORBITAN ISOSTEARATE 
TOCOPHEROL 
PHENOXYETHANOL 
CARTHAMUS TINCTORIUS SEEDCAKE 
BUTYLATED HYDROXYTOLUENE 
SUNFLOWER OIL 
CITRIC ACID MONOHYDRATE 
POTASSIUM SORBATE 
SODIUM BENZOATE 
Packaging
#Item CodePackage Description
1NDC:58668-4281-11 BOTTLE (BOTTLE) in 1 CARTON
1125 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/06/2013
Labeler - Laboratoires Clarins S.A. (503972197)
Registrant - Laboratoires Clarins S.A. (503972197)
Establishment
NameAddressID/FEIOperations
Laboratoires Clarins S.A.503972197manufacture(58668-4281)

Revised: 05/2013
 
Laboratoires Clarins S.A.

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)