CLARINS HIGH PROTECTION SUNSCREEN CARE MILK FOR CHILDREN SPF 50

Dosage form: liquid
Ingredients: TITANIUM DIOXIDE 15.6mL in 100mL, ZINC OXIDE 5.8mL in 100mL
Labeler: Laboratoires Clarins S.A.
NDC Code: 58668-4551

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 HIGH PROTECTION SUNSCREEN CARE MILK FOR CHILDREN SPF 50

Active Ingredients

Active Ingredients                          Purpose
TITANIUM DIOXIDE     15.6%    Sunscreen
ZINC OXIDE                      5.8%     Sunscreen

Uses:

• helps prevent sunburn • higher SPF gives more sunburn protection • for skin highly sensitive to sunburn

Warnings:

For external use only

When using this product:

• keep out of eyes. Rinse with water to remove

Stop use:

• rash or irritation develops and lasts

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

Directions:

• apply liberally before sun exposure and as needed • do not use on infants under 6 months of age.

Other Information:

Sun alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Inactive Ingredients:

WATER . ISOHEXADECANE . CAPRYLIC/CAPRIC TRIGLYCERIDE . POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE . POLYGLYCERYL-3 DIISOSTEARATE . ALCOHOL . BUTYLENE GLYCOL . ALUMINA . STEARIC ACID . SEA SALT . ALOE BARBADENSIS LEAF JUICE . FRAGRANCE . TOCOPHERYL ACETATE . PHENOXYETHANOL . DEHYDROACETIC ACID . TOCOPHEROL . HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . CITRIC ACID . POTASSIUM SORBATE . SODIUM BENZOATE. [S2276A]

Description

Sunscreen Care Milk For Children  100% mineral screen SPF 50+  High sun protection specially formulated for children's delicate skin.  • Does not contain any chemical filter.  • 100% UVA/UVB mineral screen.  • Water-resistant.  • For face and body.  Apply before sun exposure. Reapply at least every two hours, especially after swimming.  Allergy tested.  www.clarins.com  "CLARINS: effective, serious treatments, ensuring maximum results with the highest quality ingredients." Jacques Courtin Clarins  CLARINS PARIS - 92200 Neuilly  95300 Pontoise - France  Made in France  12 M  ref .14551  9  "CLARINS, un maximum d'efficacité par un maximum de principes actifs dans leur concentration la plus efficace." Jacques Courtin Clarins

CLARINS PARIS  50 SPF + HIGH PROTECTION UVB / UVA Sunscreen Care Milk  For children  100% mineral screen  • SHAKE BEFORE USE. 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, getmedical help or contact a Poison Control Center immediately. Directions: apply liberally before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Do not use on infants under 6months of age. Allergy tested. ACTIVE INGREDIENTS: TITANIUM DIOXIDE 15.6% . ZINC OXIDE 5.8%.  12 M  reg. 14551 9  CLARINS PARIS - 92200 Neuilly 95300 Pontoise - France  Made in France  150 mL 5.3 Oz. Net Wt.

www.clarins.com  CLARINS  SUN DAMAGE CONTROL CARE MULTI CELLULAR PROTECTION  CLARINS PARIS  50 SPF + HIGH PROTECTION UVB / UVA  Sunscreen Care Milk  for children 100% mineral screen.  e 150 mL 5.3 Oz. Net Wt.  WITH PLANT EXTRACTS  CLARINS-PARIS OC 500734 - VO

Product Inner Package Label

Product Outer Package Label

CLARINS HIGH PROTECTION SUNSCREEN CARE MILK FOR CHILDREN SPF 50 
titanium dioxide, zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-4551
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE15.6 mL  in 100 mL
ZINC OXIDE (ZINC) ZINC OXIDE5.8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOHEXADECANE 
MEDIUM-CHAIN TRIGLYCERIDES 
ALCOHOL 
BUTYLENE GLYCOL 
ALUMINUM OXIDE 
STEARIC ACID 
SEA SALT 
ALOE VERA LEAF 
PHENOXYETHANOL 
DEHYDROACETIC ACID 
TOCOPHEROL 
SUNFLOWER OIL 
CITRIC ACID MONOHYDRATE 
POTASSIUM SORBATE 
SODIUM BENZOATE 
Packaging
#Item CodePackage Description
1NDC:58668-4551-11 BOTTLE (BOTTLE) in 1 CARTON
1150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/18/2011
Labeler - Laboratoires Clarins S.A. (503972197)
Establishment
NameAddressID/FEIOperations
Laboratoires Clarins S.A.503972197manufacture

Revised: 10/2011
 
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.

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