CLARINS SELF TANNING MILK WITH SUN PROTECTION SPF 6- octinoxate, avobenzone solution 
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 Self-Tanning Milk Broad Spectrum SPF 6

Drug Facts


Active Ingredients

AVOBENZONE 2%
OCTINOXATE 6%

Purpose

Sunscreen

Uses

  • helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sun-burn, not skin cancer or early skin aging.
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
  • reapply at least every 2 hours
  • use a water resistant sunscreen 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. SORBITAN STEARATE. DIHYDROXYACETONE. C12-15 ALKYL BENZOATE. CAPRYLIC/CAPRIC TRIGLYCERIDE. ALOE BARBADENSIS LEAF JUICE. GLYCERIN. PEG-20 METHYL GLUCOSE SESQUISTEARATE. DIETHYLHEXYL SUCCINATE. STEARYL DIMETHICONE. CETYL ALCOHOL. DIMETHICONE. POLYACRYLAMIDE. ERYTHRULOSE. PARFUM/FRAGRANCE. SESAMUM INDICUM (SESAME) SEED OIL. CARBOMER. TOCOPHEROL. C13-14 ISOPARAFFIN. SODIUM METABISULFITE. PHENOXYETHANOL. HYDROXYETHYLCELLULOSE. BUTYLENE GLYCOL. BETULA ALBA BARK EXTRACT. DISODIUM EDTA. SORBIC ACID. TOCOPHERYL ACETATE. LAURETH-7. EUPATORIUM AYAPANA EXTRACT. VANILLA PLANIFOLIA FRUIT EXTRACT. POTASSIUM SORBATE. CITRIC ACID. SODIUM BENZOATE. BHT. [S0180F]

Clarins Self-Tanning Milk Broad Spectrum SPF 6 125ml (58668-7251-1)


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Outer Package 1


Outer Package 2

CLARINS SELF TANNING MILK WITH SUN PROTECTION SPF 6 
octinoxate, avobenzone solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-7251
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
DIHYDROXYACETONE (UNII: O10DDW6JOO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SESAME OIL (UNII: QX10HYY4QV)  
TOCOPHEROL (UNII: R0ZB2556P8)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BETULA PUBESCENS BARK (UNII: 3R504894L9)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SORBIC ACID (UNII: X045WJ989B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LAURETH-7 (UNII: Z95S6G8201)  
VANILLA (UNII: Q74T35078H)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58668-7251-11 in 1 PACKAGE08/29/201206/30/2018
1125 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/29/201206/30/2018
Labeler - Laboratoires Clarins S.A. (266317555)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Clarins S.A.266317555manufacture(58668-7251)

Revised: 3/2019
Document Id: 85153093-ab1e-6691-e053-2a91aa0af8a9
Set id: 2dd6d6f7-0636-4b26-9fab-19fb68ebe96c
Version: 8
Effective Time: 20190327
 
Laboratoires Clarins S.A.