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

Hydrating Antioxidant Moiturizer by

Drug Labeling and Warnings

Hydrating Antioxidant Moiturizer by is a Otc medication manufactured, distributed, or labeled by Walgreen Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone, 2.1%

Homosalate, 4.0%

Octisalate, 4.0%

Octocrylene, 2.0%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

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

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 AND PRECAUTIONS

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

QUESTIONS OR COMMENTS?

call 1-800-925-4733

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center

right away.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Other information  protect the product in this

container from excessive heat and direct sun.

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDRATING ANTIOXIDANT MOITURIZER 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0540
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.478 g  in 118 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.72 g  in 118 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.72 g  in 118 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.36   in 118 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0540-01	118 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/28/2017

Labeler - Walgreen Company (008965063)