KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN UV SERUM BROAD SPECTRUM SPF 50 PLUS SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene stick

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients

Avobenzone 2.5%

Homosalate 13.5%

Octisalate 4.3%

Octocrylene 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

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 physician 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 generously and evenly 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

octyldodecanol, propylheptyl caprylate, dicaprylyl carbonate, butylene glycol dicaprylate/dicaprate, dibutyl adipate, C12-15 alkyl benzoate, dibutyl lauroyl glutamide, dibutyl ethylhexanoyl glutamide, dextrin palmitate, hydroxyacetophenone, capryloyl salicylic acid, ascorbyl
tetraisopalmitate, tocopheryl acetate, tocopherol

Questions or comments?

Call toll free 1-800-946-4453

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN UV SERUM BROAD SPECTRUM SPF 50 PLUS SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82046-994
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	135 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	43 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDECANOL (UNII: 07UG7TSU58)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82046-994-01	18 g in 1 APPLICATOR; Type 0: Not a Combination Product	05/26/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/26/2026

Labeler - L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
HK Kolmar Canada, Inc		243501959	manufacture(82046-994)