Kiehls Super Fluid Daily UV Defense SPF 50 Plus Anti-Pollution Lightweight Formula For All Skin Types: Package Insert and Label Information

KIEHLS SUPER FLUID DAILY UV DEFENSE SPF 50 PLUS ANTI-POLLUTION LIGHTWEIGHT FORMULA FOR ALL SKIN TYPES- avobenzone, homosalate, octisalate, octocrylene and oxybenzone cream
L’Oreal USA Products Inc

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.

Active ingredients

Avobenzone 3%

Homosalate 10.7%

Octisalate 3.2%

Octocrylene 6%

Oxybenzone 3.9%

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

Flammble until dry. Do not use near fire, flame or heat.

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. — 2p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsequioxane, nylon-12, dicaprylyl carbonate, phenoxyethanol, lauryl PEG/PPG- 18/18 methicone, cellulose, sodium chloride, caprylyl glycol, PEG-8 laurate, poly C10-30 alkyl acrylate, disteardimonium hectorite, tocopherol, isostearyl alcohol, p-anisic acid, scutellaria baicalensis root extract, disodium EDTA, dodecene, poloxamer 407, propylene carbonate, triethanolamine

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KIEHLS SUPER FLUID DAILY UV DEFENSE SPF 50 PLUS ANTI-POLLUTION LIGHTWEIGHT FORMULA FOR ALL SKIN TYPES
avobenzone, homosalate, octisalate, octocrylene and oxybenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-181
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 107 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 32 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 60 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 39 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
ALCOHOL
SILICON DIOXIDE
DICAPRYLYL ETHER
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)
PEG-30 DIPOLYHYDROXYSTEARATE
DIMETHICONE
CYCLOMETHICONE 6
POLYMETHYLSILSESQUIOXANE (11 MICRONS)
NYLON-12
DICAPRYLYL CARBONATE
PHENOXYETHANOL
LAURYL PEG/PPG-18/18 METHICONE
POWDERED CELLULOSE
SODIUM CHLORIDE
CAPRYLYL GLYCOL
PEG-8 LAURATE
DISTEARDIMONIUM HECTORITE
TOCOPHEROL
ISOSTEARYL ALCOHOL
P-ANISIC ACID
SCUTELLARIA BAICALENSIS ROOT
EDETATE DISODIUM
dodecene
POLOXAMER 407
PROPYLENE CARBONATE
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-181-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 125 mL in 1 BOTTLE This package is contained within the CARTON (49967-181-01)
2 NDC:49967-181-02 1 BOTTLE in 1 CARTON contains a BOTTLE
2 50 mL in 1 BOTTLE This package is contained within the CARTON (49967-181-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2018
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
Dimensional Merchandising Inc. 076693183 manufacture (49967-181), pack (49967-181)
Establishment
Name Address ID/FEI Operations
L’Oreal USA, Inc. 185931458 manufacture (49967-181)

Revised: 01/2020 L’Oreal USA Products Inc

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