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KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS ACTIVATED SUN PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50 FOR BODY- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion 
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.

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Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

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:
• • after 80 minutes of swimming or sweating
    
  • immediately after towel drying
  • at least every 2 hours
    
• 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
  

Purpose

Sunscreen

Inactive ingredients

water, dimethicone, isododecane, styrene/acrylates copolymer, propanediol, silica, isononyl isononanoate, inulin lauryl carbamate, nylon-12, caprylyl methicone, synthetic wax, poly C10-30 alkyl acrylate, p-anisic acid, sucrose tristearate, lycium barbarum fruit extract, tocopherol, hydrolyzed triticum monococcum seed extract, phenoxyethanol, stearyl alcohol, PEG-8 laurate, triethanolamine, polymethyl methacrylate, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolyer, dimethiconol, xanthan gum, disodium EDA, glycerin

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS ACTIVATED SUN PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50 FOR BODY 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-707
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	150 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
PROPANEDIOL (UNII: 5965N8W85T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
NYLON-12 (UNII: 446U8J075B)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
SUCROSE TRISTEARATE (UNII: 71I93STU5M)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PEG-8 LAURATE (UNII: 762O8IWA10)
TROLAMINE (UNII: 9O3K93S3TK)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-707-01	150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2012	12/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2012	12/31/2018

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc.		076693183	manufacture(49967-707)

Revised: 9/2019

Document Id: 53bbf15f-8e20-41fe-8084-8c9d89de89ba

34390-5

Set id: e106cc24-7957-43ba-891d-2cbe84af339a

Version: 3

Effective Time: 20190912