MOISTURIZING FACIAL SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene,oxybenzone lotion

Moisturizing Facial Sunscreen by

Drug Labeling and Warnings

Moisturizing Facial Sunscreen by is a Otc medication manufactured, distributed, or labeled by Neoteric Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

MOISTURIZING FACIAL SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene,oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62673-164
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62673-164-03	1 in 1 CARTON	04/01/2016
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/01/2016

Labeler - Neoteric Cosmetics, Inc. (790615181)