FACE VALUES DAILY FACIAL MOISTURIZING SPF 30 SUNSCREEN- homosalate, octinoxate, zinc oxide, octocrylene aerosol, spray

FACE VALUES DAILY FACIAL MOISTURIZING SPF 30 SUNSCREEN by

Drug Labeling and Warnings

FACE VALUES DAILY FACIAL MOISTURIZING SPF 30 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by HARMON STORES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate, 8.0%, Octisalate 4.0%, Octocrylene 8.0%

Purpose

Sunscreen

Use

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

WARNINGS

For external use only

DO NOT USE

Do not use  on damaged or broken skin.

WHEN USING

When using this product  keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop use and ask a doctor if  rash occurs.

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.

Directions

• 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

Other information

• protect the product in this container from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water (purified), niacinamide, glycerin, cetearyl alcohol, cetearyl glucoside, arachidyl alcohol, arachidyl glucoside, aluminum starch octenylsuccinate, boron nitride, dimethicone, ceramide NP, ceramide AP, ceramide EOP, cholesterol, hyaluronic acid, phytophingosine, lecithin, phenoxyethanol, behenyl alcohol, steareth-2, steareth-21, disodium EDTA, sodium lauroyl lactylate, triethoxycaprylylsilane, methylparaben, propylparaben, carbomer, xanthan gum.

PRINCIPAL DISPLAY PANEL

FACE VALUE DAILY FACIAL MOISTURIZING LOTION SPF 30 SUNSCREEN

3 FL OZ (89mL)

NDC: 63940-062-18

FACE VALUE DAILY FACIAL MOISTURIZING LOTION SPF 30 SUNSCREEN

BLISTER PACK

NDC: 63940-062-19

INGREDIENTS AND APPEARANCE

FACE VALUES DAILY FACIAL MOISTURIZING SPF 30 SUNSCREEN 
homosalate, octinoxate, zinc oxide, octocrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-062
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	120 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	35 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYALURONIC ACID (UNII: S270N0TRQY)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DOCOSANOL (UNII: 9G1OE216XY)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER 934 (UNII: Z135WT9208)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-062-19	1 in 1 CARTON	10/27/2017
1	NDC: 63940-062-18	89 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/27/2017

Labeler - HARMON STORES, INC. (804085293)

Registrant - FRUIT OF THE EARTH, INC. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
FRUIT OF THE EARTH, INC.		008193513	manufacture(63940-062)