MOISTURIZING FACIAL SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene,oxybenzone lotion 
Neoteric Cosmetics, 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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Moisturizing Facial Sunscreen

Moisturizing Facial Sunscreen

Drug Facts

Active Ingredients

Avobenzone 3.0%

Active Ingredients

Homosalate 10.0%,

Active Ingredients

Octisalate 5.0%

Active Ingredients

Octocrylene 7.0%

Active Ingredients

Oxybenzone 4.5%

(to the right) 

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

• After cleansing, apply product to face and neck

• Apply liberally 15 minutes before sun exposure

• Use a water resistant sunscreen if swimming or sweating

• Reapply at least every 2 hours

• 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, especially from 10 am-2 pm

• Wear long sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Dilaurate , Glycerin, Stearic Acid, Propylene Glycol, Sodium Hyaluronate, Hydrolyzed Glycosaminoglycans, Panthenol, Tocopheryl Acetate, Sorbitan Stearate, PEG-40 Stearate, Cetyl Alcohol, Dimethicone, Vinyl Dimethicone Crosspolymer, Silica, BHT, Triethanolamine, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Disodium EDTA, Carbomer

Other Information

• Protect this product from excessive heat and direct sun.

MANUFACTURED BY NEOTERIC COSMETICS, INC., DENVER, CO 80239

BOTTOM

UPC

BOTTOM RIGHT PANEL TAB

(Item Number) 840181

PRINCIPAL DISPLAY PANEL

ALPHA
Skin Care
Moisturizing
Facial Sunscreen
SPF 30

PRINCIPAL DISPLAY PANEL ALPHA Skin Care Moisturizing Facial Sunscreen SPF 30

MOISTURIZING FACIAL SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene,oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62673-164
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE.03 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE.1 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE.05 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE.07 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE.05 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TROLAMINE (UNII: 9O3K93S3TK)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62673-164-031 in 1 CARTON04/01/2016
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/01/2016
Labeler - Neoteric Cosmetics, Inc. (790615181)

Revised: 12/2001
Document Id: 4f8e048f-23bf-491b-bbb8-3b3d623db6b8
Set id: 7e9821f1-2c1b-41e9-b161-4d2803fbb839
Version: 2
Effective Time: 20011204
 
Neoteric Cosmetics, Inc.