ULTRA VIOLETTE SHEEN SCREEN BROAD SPECTRUM HYDRATING LIP BALM DUSK- spf50 ointment

Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk by

Drug Labeling and Warnings

Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk by is a Otc medication manufactured, distributed, or labeled by Grace And Fire USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Octinoxate 5%

Octocrylene 4.7%

Purpose

Sunscreen

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

Warnings

For External use Only

Do not use

- on damaged or broken skin, when using this product

- keep out of eyes rinse with water to remove

Stop use and ask doctor if

- rash occur

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

if swallowed , call a poison control centre or get medical help right away

Directions

* Apply liberally 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 10a.m.- 2p.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, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Flavour, Caprylic/Capric Triglyceride, Tocopherol, Myrothamnus Flabellifolia Leaf/Stem Extract, Titanium Dioxide (Cl 77891), Iron Oxide Red (CI 77491).

Other Information

Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA VIOLETTE SHEEN SCREEN BROAD SPECTRUM HYDRATING LIP BALM DUSK 
spf50 ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84803-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 g
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

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
WHITE WAX (UNII: 7G1J5DA97F)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CI 77491 (UNII: 1K09F3G675)
MYROTHAMNUS FLABELLIFOLIA LEAF/STEM EXTRACT (UNII: J65B6VMC9D)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-104-01	7 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2024
2	NDC: 84803-104-02	15 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2024

Labeler - Grace And Fire USA Inc. (119357605)

Registrant - Grace And Fire USA Inc. (119357605)