FACE VALUES - AM FACIAL MOISTURIZING BROAD SPECTRUM SPF30 SUNSCREEN- homosalate, octinoxate, octocrylene, zinc oxide lotion

Face Values - AM Facial Moisturizing Broad Spectrum SPF30 Sunscreen by

Drug Labeling and Warnings

Face Values - AM Facial Moisturizing Broad Spectrum SPF30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Harmon Stores Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Homosalate 12.0%
Octinoxate 7.5%
Octocrylene 2.0%
Zinc Oxide 3.5%

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

• Apply liberally 15 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, especially 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, niacinamide, behentrimonium methosulfate, cetyl alcohol, butylene glycol, cetearyl alcohol, glycerin, aluminum starch octenylsuccinate, boron nitride, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, ceramide 3, ceramide 6- II, ceramide 1, phytosphingosine, cholesterol, sodium lauroyl lactylate, carbomer, xanthan gum, dimethicone, disodium EDTA, hyaluronic acid

Package/Label Principal Display Panel

Harmon® FaceValuesTM AM Facial Moisturizing Lotion
Broad Spectrum SPF30 Sunscreen
moisturize
restore
maintain

moisturizes to help repair & restore skin's protective barrier 

with Ceramides & UVA/UVB Protection

Non-comedogenic

Compare Ours to the Active ingredients in CeraVe®
AM Facial Moisturizing Lotion*

3 Fl Oz (89 mL)

Distributed by
Harmon Stores, Inc.
650 Liberty Ave.
Union, NJ 07083 USA
©Harmon Stores, Inc.
Visit us at:
www.facevalues.com

Manufactured in Israel

8D121 B1 C1

*This product is not manufactured or distributed by Coria Laboratories Ltd,
owner of the registered trademark CeraVeTM.

Label

INGREDIENTS AND APPEARANCE

FACE VALUES - AM FACIAL MOISTURIZING BROAD SPECTRUM SPF30 SUNSCREEN 
homosalate, octinoxate, octocrylene, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	12 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
CETYL ALCOHOL (UNII: 936JST6JCN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BORON NITRIDE (UNII: 2U4T60A6YD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-121-11	1 in 1 CARTON
1		89 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/15/2013

Labeler - Harmon Stores Inc (804085293)