FDA.reportPublic FDA data

Quick Wrinkle Repair Moisturizer Broad Spectrum SPF30

Manufacturer
Harmon Stores Inc
Effective date
2013-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:28

Label at a glance#

ProductQuick Wrinkle Repair Moisturizer Broad Spectrum SPF30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure12 sections

Indications and 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

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%
Homosalate 4.0%
Octisalate 4.0%
Octocrylene 2.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use on

OTC - DO NOT USE SECTION

  • damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs.

Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

For Best Results:

Apply daily to cleansed face and neck. Smooth a pearl-sized amount evenly in gentle massaging strokes until full absorbed. Works well under makeup.

Other Information

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, decamethyltetrasiloxane, isononyl isononanoate, glycerin, cetyl alcohol, steareth-21, nylon-12, silica, stearyl alcohol, glyceryl stearate, PEG-100 stearate, phenoxyethanol, ethylhexylglycerin, dimethicone, dimethicone crosspolymer, fragrance, sodium styrene/acrylates divinylbenzene copolymer, ammonium nonoxynol-4-sulfate, propylene glycol, myrtus communis extract, xanthan gum, sodium hydroxide, retinyl palmitate, polysorbate 20, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, ascorbic acid, BHT, hyaluronic acid

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Harmon® FaceValuesTM Quick Wrinkle Repair Moisturizer
Broad Spectrum SPF30 Sunscreen
Visible results within a short time

Compare Ours to the Active Ingredients in Neutrogena®
Rapid Wrinkle Repair Moisturizer - SPF 30*

1 Fl Oz (29 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

3X310 B1 C1

*This product is not manufactured or distributed by Neutrogena®, owner of the Rapid Wrinkle Repair Moisturizer.

Label
Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63940-310-112020-01-31C16284748780-19d75b9d1-0d11-f424-e053-dadaa90a57ceHarmon ® FaceValues ™ Quick Wrinkle Repair Moisturizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63940-310-11Quick Wrinkle Repair Moisturizer Broad Spectrum SPF3029 mL in 1 BOTTLE, PUMPCREAM291

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63940-310QUICK WRINKLE REPAIR MOISTURIZER BROAD SPECTRUM SPF30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [HARMON STORES INC]1Legacy NDC, 1 package rows20131115_74375c1e-5b18-42be-bcb7-9d85388da5f1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
AMMONIUM NONOXYNOL-4 SULFATEINACTIVE INGREDIENT9HIA70O4J01
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5CO1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
DECAMETHYLTETRASILOXANEINACTIVE INGREDIENTC23WAL597T1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERINACTIVE INGREDIENTRSA9I561OK1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQY1
ISONONYL ISONONANOATEINACTIVE INGREDIENTS4V5BS6GCX1
MYRTUS COMMUNIS LEAFINACTIVE INGREDIENTU20N87188F1
NYLON-12INACTIVE INGREDIENT446U8J075B1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679Z1
STEARETH-21INACTIVE INGREDIENT53J3F32P581
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63940-31063940-310-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
DECAMETHYLTETRASILOXANEC23WAL597TIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
STEARETH-2153J3F32P58IACT
NYLON-12446U8J075BIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERRSA9I561OKIACT
AMMONIUM NONOXYNOL-4 SULFATE9HIA70O4J0IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MYRTUS COMMUNIS LEAFU20N87188FIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
POLYSORBATE 207T1F30V5YHIACT
EDETATE DISODIUM7FLD91C86KIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
HYALURONIC ACIDS270N0TRQYIACT
SODIUM POLYSTYRENE SULFONATE1699G8679ZIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 11 · 642 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCAPSULE, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUPPOSITORY / RECTAL3 mgExact identifier — unii candidate
25 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INTRAVENOUS4 mgExact identifier — unii candidate
25 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVESICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAMUSCULAR176 mgExact identifier — unii candidate
174 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / SUBCUTANEOUSNAExact identifier — unii candidate
174 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / VAGINAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPRAY / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHPOWDER, FOR SUSPENSION / ORAL1.3 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, DELAYED RELEASE / ORAL0.25 mgExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / VAGINAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / RESPIRATORY (INHALATION)0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATE1699G8679ZCAPSULE, EXTENDED RELEASE / ORAL170.4 mgExact identifier — unii candidate
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBCONJUNCTIVALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
74375c1e-5b18-42be-bcb7-9d85388da5f174375c1e-5b18-42be-bcb7-9d85388da5f12013-11-12WarningsExact identifier
spl id: 74375c1e-5b18-42be-bcb7-9d85388da5f1
spl set id: 74375c1e-5b18-42be-bcb7-9d85388da5f1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.