FDA.reportPublic FDA data

Enhanced Facial Moisturizer

Manufacturer
Neoteric Cosmetics, Inc.
Effective date
2024-10-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:45:24

Label at a glance#

ProductEnhanced Facial Moisturizer
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure9 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

• After cleansing, apply product to face and neck • Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply 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 SP...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Enhanced Facial Moisturizer

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Zinc Oxide 5.0%

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 damaged or broken skin

OTC - DO NOT USE SECTION

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

• Stop use and ask a doctor if rash occurs

OTC - STOP USE SECTION

• 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

• After cleansing, apply product to face and neck

• Apply liberally 15 minutes before sun exposure

• Use a water resistant sunscreen if swimming or sweating

• Reapply 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 am-2 pm

• Wear long sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Peroxidized Corn Oil, Soybean Oil, Dicaprylyl Carbonate, Polyacrylamide, C13-14 Isoparaffin, Laureth7, Steareth 21, Glycerin, Dimethicone, Myristyl Myristate, Petrolatum, Tocopheryl Acetate (Vitamin E), Panthanol (Vitamin B5), Green Tea Extract, Lactic Acid, Cetyl Alcohol, Xanthan Gum, Disodium EDTA, Steareth 2, Mica, Titanium Dioxide, BHT, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Triethoxycaprylylsilane, Propylene Glycol

Other Information

OTHER SAFETY INFORMATION

• Protect this product from excessive heat and direct sun.

MANUFACTURED BY NEOTERIC COSMETICS, INC., DENVER, CO 80239

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alpha
skin care
Enhanced
Facial Moisturizer
SPF 15
Net Wt. 1 oz. (28g)

PRINCIPAL DISPLAY PANEL Alpha skin care Enhanced Facial Moisturizer SPF 15 Net Wt. 1 oz. (28g)PRINCIPAL DISPLAY PANEL Alpha skin care Enhanced Facial Moisturizer SPF 15 Net Wt. 1 oz. (28g)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62673-163-012024-12-18C16284748780-1ab0e2407-2f9f-f274-e053-dbdaa90a6471Enhanced Facial Moisturizer
62673-163-012020-09-27C16284748780-1ab0e2407-2f9f-f274-e053-dbdaa90a6471Enhanced Facial Moisturizer
62673-163-012020-09-25C16284748780-1ab0e2407-2f9f-f274-e053-dbdaa90a6471Enhanced Facial Moisturizer
62673-163-012020-07-22C16284748780-1ab0e2407-2f9f-f274-e053-dbdaa90a6471Enhanced Facial Moisturizer

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62673-16362673-163-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CORN OIL8470G57WFMIACT
SOYBEAN OIL241ATL177AIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
STEARETH-2153J3F32P58IACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
PETROLATUM4T6H12BN9UIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTOTHENIC ACID19F5HK2737IACT
STEARETH-2V56DFE46J5IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TROLAMINE9O3K93S3TKIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

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
23e934bd-8dca-d3e4-e063-6394a90a2aa7c1e11e88-5e10-4dc0-882a-29eef783b9942024-10-07WarningsExact identifier
spl id: 23e934bd-8dca-d3e4-e063-6394a90a2aa7
spl set id: c1e11e88-5e10-4dc0-882a-29eef783b994

Reported adverse events (FAERS/openFDA)#

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