CLARINS BROAD SPECTRUM SPF 15 SUNSCREEN CARE FOR OUTDOOR SPORTS- avobenzone, homosalate, octisalate, octocrylene spray 
Laboratoires Clarins S.A.

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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Clarins Broad Spectrum SPF 15 Sunscreen Care Oil-Free Lotion Spray For Outdoor Sports

Clarins Broad Spectrum SPF 15 Sunscreen Care Oil-Free Lotion Spray For Outdoor Sports


Active ingredients

AVOBENZONE  3%
HOMOSALATE  10%
OCTISALATE  5%
OCTOCRYLENE  2.7%

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 medical 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 increases 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
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

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

  • ALCOHOL . OCTYLDODECANOL . BUTYLOCTYL SALICYLATE . POLYESTER-7 . NEOPENTYL GLYCOL DIHEPTANOATE . PARFUM/FRAGRANCE . TOCOPHERYL ACETATE . BENZYL SALICYLATE . ETHYLENE BRASSYLATE . LIMONENE . BUTYLPHENYL METHYLPROPIONAL . ALOE BARBADENSIS LEAF JUICE . BUTYLENE GLYCOL . GLYCERIN . AQUA/WATER/EAU . HEXYL CINNAMAL . CITRONELLOL . CASSIA ALATA LEAF EXTRACT . CITRIC ACID  POTASSIUM SORBATE .SODIUM BENZOATE.[S1234C]

Clarins Broad Spectrum SPF 15 Sunscreen Care Oil-Free Lotion Spray For Outdoor Sports 150ml (58668-4061-1)

BoxLabelInnerLabel

CLARINS BROAD SPECTRUM SPF 15 SUNSCREEN CARE FOR OUTDOOR SPORTS 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-4061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
POLYESTER-7 (UNII: 0841698D2F)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58668-4061-11 in 1 CARTON10/23/201312/15/2019
1150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/23/201312/15/2019
Labeler - Laboratoires Clarins S.A. (266317555)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Clarins S.A.266317555manufacture(58668-4061)

Revised: 11/2021
 
Laboratoires Clarins S.A.