HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN 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]

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

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HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN LOTION

Active Ingredients

Avobenzone 2.7%,

Homosalate 4.0%,

Octisalate 4.5%,

Octocrylene 6.0%,

Oxybenzone 4.5%

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 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 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
• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

acrylates/dimethicone copolymer, 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, tocopherol, trideceth-6, water, xanthan gum

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: 63940-081
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
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
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)
KONJAC MANNAN (UNII: 36W3E5TAMG)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-7 (UNII: 0841698D2F)
PURSLANE (UNII: M6S840WXG5)
SARCOSINE (UNII: Z711V88R5F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
STEARETH-100 (UNII: 4OH5W9UM87)
STEARETH-2 (UNII: V56DFE46J5)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FARNESOL (UNII: EB41QIU6JL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-081-94	177 mL in 1 TUBE; Type 0: Not a Combination Product	01/11/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/11/2021	07/25/2025

Labeler - Harmon Stores Inc. (804085293)

Revised: 10/2024

Document Id: 2502e4cf-8335-0f59-e063-6394a90a0b43

34390-5

Set id: d4de2243-6ff8-1d9b-e053-2a95a90a1345

Version: 4

Effective Time: 20241021