FDA.reportPublic FDA data

NUDIST LIP BUTTER

Manufacturer
ROYAL COSMETICS CORPORATION
Effective date
2020-02-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:46

Label at a glance#

ProductNUDIST LIP BUTTER afterglow
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

• Helps prevent sunburn.

Dosage and administration

Apply liberally to the lips.  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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• Helps prevent sunburn.

Warnings

WARNINGS SECTION

  • For external use only.
  • Do not use on damaged or broken skin.
  • Stop use and ask doctor if skin rash occurs.
  • When using this product keep out of eyes. Rinse with water to remove. 
  • Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

Apply liberally to the lips. 

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Castor Isostearate Succinate, Acacia Decurrens/Jojoba/Sunflower Seed Wax/Polyglyceryl-Esters, Tribehenin, Oleic/Linoleic/Lonolenic
Polyglycarides, Euphorbia Cerifera (Candelila) Wax*, Simmondsia Chinensis (Jojoba) Oil*, Helianthus Annuus (Sunflower) Seed Oil*,
Rubus Idaeus (Red Raspberry) Seed Oil*, Daucus Carota Sativa (Carrot) Seed Oil*, Mixed Tocopherols, Camellia Sinensis Leaf Extract*,
Mentha Spicata (Spearmint)*, Vanilla Planifolia Fruit*. [± Iron Oxide (CI 77491, 77492, 77499), D & C Red 33 (CI 17200), D&C Red No. (CI
15850), Manganese Violet (CI 77742), Mica (CI 77019)

*ORGANIC INGREDIENTS

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun. This is a water reisstant product.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67597-001-012022-01-28C16284748780-1d6a99b39-a119-a426-e053-dadaa90af4c22aec0621-6225-475d-b476-eb38a4885151

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67597-001-01NUDIST LIP BUTTERafterglow1 in 1 CARTONSTICK11
67597-001-01NUDIST LIP BUTTERafterglow2 g in 1 BOTTLE, PLASTICSTICK21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67597-001NUDIST LIP BUTTER AFTERGLOW (ZINC OXIDE) STICK [ROYAL COSMETICS CORPORATION]1Legacy NDC, 2 package rows20200219_2aec0621-6225-475d-b476-eb38a4885151.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67597-00167597-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ACACIA DECURRENS FLOWER8PHF3LSM61IACT
TRIBEHENIN8OC9U7TQZ0IACT
JOJOBA OIL724GKU717MIACT
CANDELILLA WAXWL0328HX19IACT
LINOLEIC ACID9KJL21T0QJIACT
ISOSTEARIC ACIDX33R8U0062IACT
SUCCINIC ACIDAB6MNQ6J6LIACT
CASTOR OILD5340Y2I9GIACT
SUNFLOWER OIL3W1JG795YIIACT
RASPBERRY SEED OIL9S8867952AIACT
CARROT SEED OIL595AO13F11IACT
TOCOPHEROLR0ZB2556P8IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MENTHA SPICATA OILC3M81465G5IACT
VANILLA BEANQ74T35078HIACT

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
33abe62f-fed2-478b-9739-55d75e5867822aec0621-6225-475d-b476-eb38a48851512020-02-06WarningsExact identifier
spl id: 33abe62f-fed2-478b-9739-55d75e586782
spl set id: 2aec0621-6225-475d-b476-eb38a4885151

Reported adverse events (FAERS/openFDA)#

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