HYDRATING ANTIOXIDANT MOITURIZER- avobenzone, homosalate, octisalate, octocrylene cream 
Walgreen Company

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, 2.1%

Homosalate, 4.0%

Octisalate, 4.0%

Octocrylene, 2.0%

Purpose

Sunscreen

Uses  •helps prevent sunburn  •If used as directed

with other 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.

WARNINGS: FOR EXTERNAL USE ONLY.

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE

THOROUGHLY WITH WATER. IF IRRITATION OR RASH OCCURS,

DISCONTINUE USE. KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, SEEK MEDICAL ATTENTION OR CONTACT  POISON

CONTROL CENTER RIGHT AWAY.

QUESTIONS OR COMMENTS?

call 1-800-925-4733

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center

right away.

Directions

•apply liberally 5 minutes before sun exposure

•reapply at least every 2 hours

•use water resistant sunscreen if swimming or

sweating.

•children under 6 months of age: ask a doctor.

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, specially from 10 a.m. - 2 p.m.

   •wear long-sleeved shirts, pants, hats and sunglasses.

Other information  •protect the product in this

container from excessive heat and direct sun.

Inactive ingredients  Water, Dimethicone,

Trisiloxanane, Isononyl Isononanoate, Glycerin, Cetyl Alcohol,

Steareth-21, Nylon-12, Silica, Stearyl Alcohol, Glyceryl Stearate,

PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin,

Dimethicone Crosspolymer, Fragrance, Propylene Glycol,

Myrtus Communis Extract, Xanthan Gum, Retinyl Palmitate, Polysorbate 20, Carbomer,

Disodium EDTA, Ascorbic Acid, Sodium Hydroxide, ,BHT, Hyaluronic Acid.

image description

HYDRATING ANTIOXIDANT MOITURIZER 
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0540
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.478 g  in 118 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.72 g  in 118 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.72 g  in 118 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.36   in 118 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARETH-21 (UNII: 53J3F32P58)  
NYLON-12 (UNII: 446U8J075B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MYRTUS COMMUNIS LEAF (UNII: U20N87188F)  
XANTHAN GUM (UNII: TTV12P4NEE)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
HYALURONIC ACID (UNII: S270N0TRQY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0540-01118 mL in 1 PACKAGE; Type 0: Not a Combination Product10/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/28/2017
Labeler - Walgreen Company (008965063)

Revised: 11/2017
Document Id: 8fb13b3f-184b-4491-adfa-a8d924801682
Set id: dbf44ea9-1073-4a8f-b44b-2bf1a1b48081
Version: 1
Effective Time: 20171109
 
Walgreen Company