HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN by

Drug Labeling and Warnings

HARMON FACE VALUES BREAK-OUT FREE SPF 55 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 2.7%, Homosalate 4.0%, Octisalate 4.5%, Octocrylene 6.0%, Oxybenzone 4.5%

Purpose

Skin Protectant

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

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 immediately.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:

    after 80 minutes of swimming or sweating

    immediately after towel drying

    at least every 2 hours

    children under 6 months: 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 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-sleeve shirts, pants, hats, and sunglasses

Other information

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

Inactive Ingredients

acrylates/dimethicone copolymer, BHT, bisabolol, butylene glycol, C12-15 alkyl benzoate, capryloyl glycine, caprylyl glycol, cedrus atlantica bark extract, cetyl dimethicone, chlorphenesin, cinnamomum zeylanicum bark extract, dimethicone, disodium EDTA, ethylhexyl stearate, ethylhexylglycerin, glycerin, mannan, neopentyl glycol diheptanoate, phenoxyethanol, polyester-7, portulaca oleracea extract, sarcosine, silica, sodium polyacrylate, steareth-100, steareth-2, styrene/acrylates copolymer, trideceth-6, water, xanthan gum

Questions or comments?

1-800-527-7731

PRINCIPAL DISPLAY PANEL

ALUES BREAK-OUT FREE SPF 55 SUNSCREEN LOTION TWIN PACK

(2x) 3 FL OZ (88mL)

NDC: 63940-051-09

INGREDIENTS AND APPEARANCE

HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	40 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
CHLORPHENESIN (UNII: I670DAL4SZ)
CINNAMON BARK OIL (UNII: XE54U569EC)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
YEAST MANNAN (UNII: 91R887N59P)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-7 (UNII: 0841698D2F)
PURSLANE (UNII: M6S840WXG5)
SARCOSINE (UNII: Z711V88R5F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
STEARETH-100 (UNII: 4OH5W9UM87)
STEARETH-2 (UNII: V56DFE46J5)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-051-10	2 in 1 PACKAGE	02/27/2017
1	NDC: 63940-051-09	88 mL 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 not final	part352	02/27/2017

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(63940-051)