HARMON FACE VALUES REFRESHING COOLING BODY MIST SUNSCREEN SPF 45 CONTINUOUS SPRAY

HARMON FACE VALUES REFRESHING COOLING BODY MIST SUNSCREEN SPF 45 by

Drug Labeling and Warnings

HARMON FACE VALUES REFRESHING COOLING BODY MIST SUNSCREEN SPF 45 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 REFRESHING COOLING BODY MIST SUNSCREEN SPF 45- avobenzone, homosalate, octisalate, octocrylene aerosol, spray 
HARMON STORES, INC.

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HARMON FACE VALUES REFRESHING COOLING BODY MIST SUNSCREEN SPF 45 CONTINUOUS SPRAY

Active ingredients

Avobenzone 3.0%, Homosalate, 15.0%, Octisalate 5.0%, Octocrylene 2.35%

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

FLAMMABLE:

• do not use near heat, flame or while smoking
• avoid long term storage above 104°F (40°C)

Do not use

 on damaged or broken skin.

When using this product

 keep out of eyes. Rinse with water to remove. do not puncture or incinerate. Contents under pressure. do not store at temperatures above 120°F.

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

• Spray liberally and spread evenly by hand 15 minutes before sun exposure
• Hold can 4-6 inches away from skin to apply
• Do not spray into face. Spray into hand and apply to face.
• Use in well ventilated area
• reapply:

    after 80 minutes of swimming or sweating

    immediately after towel drying

    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 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

alcohol denat., tridecyl salicylate, diethylhexyl 2,6-naphthalate, acrylates/octylacrylamide copolymer, dimethicone, trisiloxane, PPG-5-ceteth-20, cyclopentasiloxane, propylene glycol, menthyl lactate, ethoxydiglycol, acrylates/dimethicone copolymer, retinyl palmitate, phospholipids, fragrance, tocopheryl acetate, ascorbyl palmitate, water, beta-carotene.

Label

HARMON FACE VALUES REFRESHING COOLING BODY MIST SUNSCREEN SPF 45 
avobenzone, homosalate, octisalate, octocrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-086
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRISILOXANE (UNII: 9G1ZW13R0G)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
WATER (UNII: 059QF0KO0R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BETA CAROTENE (UNII: 01YAE03M7J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-086-88	226 g in 1 CAN; Type 0: Not a Combination Product	04/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/17/2020	03/16/2025

Labeler - HARMON STORES, INC. (804085293)

Revised: 10/2024

Document Id: 25031e2f-6db6-877b-e063-6394a90a652d

34390-5

Set id: f0f0e4cd-3148-4c1a-e053-2995a90a64eb

Version: 2

Effective Time: 20241021