Active Ingredients

Manufacturer
Grace and Fire USA Inc.
Effective date
2026-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:55:35

Label at a glance#

ProductUltra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50
Active ingredientAVOBENZONE, OCTOCRYLENE, OCTISALATE
Label structure8 sections

Dosage and administration

Directions for Sunscreen Use apply liberally and evenly 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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 inclu...

Storage and handling

other informatom protect the rproduct in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3.0%

OCTINOXATE 5%

OCTOCRYLENE 4.7%

purpose

OTC - PURPOSE SECTION

SUNSCREEN

Use

INDICATIONS & USAGE SECTION

HELPS PREVENT SUNBURN

IF USE A DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN

WARNINGS SECTION

.

FOR EXTERNAL USE ONLY

OTC - DO NOT USE SECTION

.

DO NOT USE

OTC - DO NOT USE SECTION

ON DAMAGED OR BROKEN SKIN

WHEN USING THS PRODUCT

OTC - WHEN USING SECTION

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE AND ASK DOCTOR

OTC - STOP USE SECTION

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

Directions for Sunscreen Use

apply liberally and evenly 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

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

children under 6 months of age: Ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lanolin, Theobroma Cacao (Cocoa) Seed Butter, Cera Alba, Ricinus Communis (Castor) Seed Oil, Butyrospermum Parkii (Shea) Butter, Flavour, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Capyrylic/ Capric Triglyceride, Tocopherol, Myrothamnus Flabellifolia Leaf/Stem Extract, BHT, Limonene, Linalool, Titanium Dioxide (Cl 77891), Red 33 Lake (Cl 17200), Red 30 Lake (Cl 73360).

other information

STORAGE AND HANDLING SECTION

other informatom protect the rproduct in this container from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

silk pillowsilk pillowUltra Violette

Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50

15g 0.5oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84803-114-15Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 5015 g in 1 TUBEOINTMENT151

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84803-11484803-114-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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
Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50AVOBENZONE, OCTINOXATE, OCTOCRYLENEGrace and Fire USA Inc.4df6d28b-64ce-59b3-e063-6394a90a63602026-05-01WarningsExact identifier
ndc (package): 84803-114-15
ndc (product): 84803-114
ndc11 (package): 84803011415
spl id: 4df6d28b-64cf-59b3-e063-6394a90a6360
spl set id: 4df6d28b-64ce-59b3-e063-6394a90a6360

Reported adverse events (FAERS/openFDA)#

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