FDA.reportPublic FDA data

Daily Face Cream Broad Spectrum SPF 20

Manufacturer
Goodier Cosmetics LLC
Effective date
2021-10-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:19

Label at a glance#

ProductZinc Oxide
Active ingredientZINC OXIDE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DAILY FACE
CREAM


SUNSCREEN
ZINC OXIDE
BROAD SPECTRUM SPF 20

PATENTED
NERIUM ALOE
EXTRACT
NAE-8®

OTC - ACTIVE INGREDIENT SECTION

Active                                             Ingredient Purpose
Zinc Oxide 12.5%............................Sunscreen

INDICATIONS & USAGE SECTION

Uses
• Helps prevent sunburn
• Higher SPF gives more sunburn protection
• Provides moderate protection against 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 SECTION

Warnings
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 or
irritation develops and lasts

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed,
get medical help or contact a Poison Control
Center right away.

INSTRUCTIONS FOR USE SECTION

Directions
• Apply generously before sun exposure and as needed
• 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 SAFETY INFORMATION

Other Information
• Storage: Transport and store in a cool, dry
area. Keep away from direct sunlight.
• Moderate sun protection product.
• Sun alert: limiting sun exposure, wearing
protective clothing, and using sunscreens may
reduce the risks of skin aging, skin cancer,
and other harmful effects of the sun.
• Protect the product in this container from
excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Water, C12-15 Alkyl Benzoate, Glycerin, Aloe Barbadenis Leaf Juice, Cetearyl Alcohol,
Ceteth-20 Phosphate, Oleth-3 Phosphate, Isostearic Acid, Silica, Nerium Oleander Leaf
Extract (NAE-8®), Hydrolyzed Egg Shell Membrane (Peptide Matrix - Collagen & Elastin),
Caprylyl Glycol, Leuconostoc/Radish Root Ferment Filtrate, Superoxide Dismutase,
Polygonum Aviculare Extract, Dimethicone, Cetearyl Glucoside, Niacinamide, Sodium
Hyaluronate, Tetrahexyldecyl Ascorbate, Glyceryl Caprylate, Avena Sativa (Oat) Kernel Extract,
Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract,
Tocopheryl Acetate, Dipotassium Glycyrrhizinate, Palmitoyl Dipeptide-5 Diaminobutyroyl
Hydroxythreonine, Palmitoyl Tripeptide-5, Tetradecyl Aminobutyroylvalylaminobutyric Urea
Trifluoroacetate, Glyceryl Stearate Citrate, Magnesium Chloride, Xanthan Gum,
Disodium EDTA, Phenylpropanol, Dicetyl Phosphate, Polyhydroxystearic Acid, Potassium
Sorbate, Fragrance, Mica, Titanium Dioxide, Pentylene Glycol, Phenoxyethanol, Sodium
Benzoate, Tromethamine

OTC - QUESTIONS SECTION

Questions?
1-(866)-535-5888 M-F (9 am to 5 pm CST)

SPL UNCLASSIFIED SECTION

Manufactured for:
Nerium SkinCare, Inc.
San Antonio, TX 78230

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pure Daily Face Cream SPF20Pure Daily Face Cream SPF20

1floz Pure Daily Face Cream

Advanced Daily Face Cream SPF20Advanced Daily Face Cream SPF20

1floz Advanced Daily Face Cream

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10477-1384-12023-01-30C16284748780-1f386c649-9ea7-0266-e053-dadaa90a7c1aDaily Face Cream Broad Spectrum SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10477-1384-1Zinc Oxide30 g in 1 BOTTLE, PUMPLOTION303
10477-1384-1Zinc Oxide1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10477-1384ZINC OXIDE (DAILY FACE CREAM BROAD SPECTRUM SPF 20) LOTION [GOODIER COSMETICS LLC]3Legacy NDC, 2 package rows20211020_6199a79c-c1a3-40e7-9553-3c420b5e75ae.zip

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10477-138410477-1384-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAF POLYSACCHARIDESW21O437517IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20 PHOSPHATE921FTA1500IACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
ISOSTEARIC ACIDX33R8U0062IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
NERIUM OLEANDER LEAF7KV510R6H6IACT
EGG SHELL MEMBRANEN7QBR4212VIACT
CAPRYLYL GLYCOL00YIU5438UIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
SUPEROXIDE DISMUTASE (MN) SACCHAROMYCES CEREVISIAE0192074X0KIACT
POLYGONUM AVICULARE WHOLEM990N03611IACT
DIMETHICONE92RU3N3Y1OIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
NIACINAMIDE25X51I8RD4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
OATZ6J799EAJKIACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZIACT
ROSEMARYIJ67X351P9IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE1615WE9073IACT
PALMITOYL TRIPEPTIDE-52A3916MQHOIACT
TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE0UBP26S1LGIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
MAGNESIUM CHLORIDE02F3473H9OIACT
XANTHAN GUMTTV12P4NEEIACT
DISODIUM ETHYLENEDIAMINEDIACETATEEQL53S5L0FIACT
PHENYLPROPANOL0F897O3O4MIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PENTYLENE GLYCOL50C1307PZGIACT

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
cebb8f94-5ce1-2c13-e053-2a95a90aed106199a79c-c1a3-40e7-9553-3c420b5e75ae2021-10-19WarningsExact identifier
spl id: cebb8f94-5ce1-2c13-e053-2a95a90aed10
spl set id: 6199a79c-c1a3-40e7-9553-3c420b5e75ae

Reported adverse events (FAERS/openFDA)#

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