KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS AUTOTONE DISCOLORATION AND UV SOLUTION BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

Kiehls Since 1851 Dermatologist Solutions AutoTone Discoloration and UV Solution Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Kiehls Since 1851 Dermatologist Solutions AutoTone Discoloration and UV Solution Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

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

Directions

For sunscreen 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. – 2 p.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, C15-19 alkane, niacinamide, glycerin, butylene glycol, silica, titanium dioxide, hydroxyacetophenone, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, potassium hydroxide, sodium thiosulfate, taraxacum officinale (dandelion) rhizome/root extract, trisodium ethylenediamine disuccinate, 2-mercaptonicotinoyl glycine, butyrospermum parkii (shea) butter, ammonium acryloyldimethyltaurate/VP copolymer, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, caprylyl glycol, carbomer, citric acid, mica, pentylene glycol, poly c10-30 alkyl acrylate, polyglyceryl-4 caprate, sodium dilauramidoglutamide lysine, tin oxide, xanthan gum, red 4, phenoxyethanol

Questions or comments?

Call toll free 1-800-946-4453

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS AUTOTONE DISCOLORATION AND UV SOLUTION BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C15-19 ALKANE (UNII: CI87N1IM01)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM THIOSULFATE (UNII: HX1032V43M)
TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SHEA BUTTER (UNII: K49155WL9Y)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MICA (UNII: V8A1AW0880)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
STANNIC OXIDE (UNII: KM7N50LOS6)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-069-01	1 in 1 CARTON	06/15/2024
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-069-02	1 in 1 CARTON	06/15/2024
2		15 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-069-03	2 mL in 1 PACKET; Type 0: Not a Combination Product	06/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/15/2024

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-069)