FDA.reportPublic FDA data

FACE VALUES OIL-FREE SPF 15 FACIAL MOISTURIZING LOTION

Manufacturer
HARMON STORES, INC.
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:28:02

Label at a glance#

ProductFACE VALUES SPF 15 FACIAL MOISTURIZER
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE
Label structure13 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 3.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

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 prevent sunburn, not skin cancer or early skin aging.

For external use only

OTC - DO NOT USE SECTION

Do not use • on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if • rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is 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 a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, octyldodecyl neopentanoate, glycerin, cetearyl alcohol, polysorbate 60, glyceryl stearate, PEG-100 stearate, dimethicone, triethanolamine, diazolidinyl urea, methylparaben, ethylparaben, propylparaben, carbomer

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-527-7731

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FACE VALUES OIL-FREE SPF 15 MOISTURIZING LOTION

4 FL OZ (118mL)

NDC 63940-069-04

LabelFrontLabelFrontLabelBackLabelBack

FACE VALUES OIL-FREE SPF 15 MOISTURIZING LOTION

BLISTER PACK

NDC 63940-069-05

Blister PackBlister Pack

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63940-073-052021-10-21C16284748780-1c7ccaba7-0f45-fd44-e053-dadaa90aa01bFACE VALUES OIL-FREE SPF 15 FACIAL MOISTURIZING LOTION
63940-073-052021-07-23C16284748780-1c7ccaba7-0f45-fd44-e053-dadaa90aa01bFACE VALUES OIL-FREE SPF 15 FACIAL MOISTURIZING LOTION

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63940-073FACE VALUES SPF 15 FACIAL MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [HARMON STORES, INC.]4Legacy NDC20241023_7afc6766-2262-4f40-b62f-8d39860da113.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63940-07363940-073-04, 63940-073-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
DIMETHICONE92RU3N3Y1OIACT
TROLAMINE9O3K93S3TKIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
PROPYLPARABENZ8IX2SC1OHIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML · Source PDF

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
2502d24b-8146-bbc4-e063-6394a90a80037afc6766-2262-4f40-b62f-8d39860da1132024-10-21WarningsExact identifier
spl id: 2502d24b-8146-bbc4-e063-6394a90a8003
spl set id: 7afc6766-2262-4f40-b62f-8d39860da113

Reported adverse events (FAERS/openFDA)#

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