ULTRA VIOLETTE SHEEN SCREEN HYDRATING LIP BALM SILK PILLOW BROAD SPECTRUM SPF 50- avobenzone, octinoxate, octocrylene ointment

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients

AVOBENZONE 3.0%

OCTINOXATE 5%

OCTOCRYLENE 4.7%

purpose

SUNSCREEN

Use

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

.

FOR EXTERNAL USE ONLY

.

DO NOT USE

ON DAMAGED OR BROKEN SKIN

WHEN USING THS PRODUCT

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE AND ASK DOCTOR

RASH OCCURS

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

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

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

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

PRINCIPAL DISPLAY PANEL

Ultra Violette

Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50

15g 0.5oz

INGREDIENTS AND APPEARANCE

ULTRA VIOLETTE SHEEN SCREEN HYDRATING LIP BALM SILK PILLOW BROAD SPECTRUM SPF 50 
avobenzone, octinoxate, octocrylene ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84803-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.7 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BHT (UNII: 1P9D0Z171K)
CI 17200 (UNII: 9DBA0SBB0L)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)
LINALOOL (UNII: D81QY6I88E)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LANOLIN (UNII: 7EV65EAW6H)
MYROTHAMNUS FLABELLIFOLIA LEAF (UNII: 6Y9E0R40J5)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
CI 73360 (UNII: 2S42T2808B)
WHITE WAX (UNII: 7G1J5DA97F)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-114-15	15 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2026

Labeler - Grace and Fire USA Inc. (119357605)