ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE CARAMEL- octinoxate, zinc oxide stick

Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Caramel by

Drug Labeling and Warnings

Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Caramel by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, BEL STAR S A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Octinoxate 7.50% Sunscreen

Zinc Oxide 4.90% Sunscreen

PURPOSE

Uses

• Helps prevent sunburn.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
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.

DOSAGE & ADMINISTRATION

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients: octyldodecanol, ethylhexyl palmitate, polyethylene, ozokerite, silica, jojoba esters, copernicia cerifera (carnauba) wax, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, helianthus annuus (sunflower) seed wax, hexyl laurate, tocopheryl acetate, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, schinus terebinthifolia seed extract, phenoxyethanol, tridecyl stearate, dimethicone, acacia decurrens flower wax, polyglycerin-3, triethoxycaprylylsilane, neopentyl glycol dicaprylate/dicaprate, caprylyl glycol, chlorphenesin, trimethylsiloxysilicate, ceramide np, lecithin.
may contain:
mica, titanium dioxide, synthetic fluorphlogopite, iron oxides, yellow 5 lake, red 7 lake, red 6 lake, talc.

OTHER SAFETY INFORMATION

Other information

• Protect the product in this container from excessive heat and direct sun

Ultra Balm SPF 20 Nude Caramel

L'BEL

ULTRA BALM

Moisturizing protective balm for lips SPF 20 Nude Caramel

Net. Wt. 0.14 oz (4 g)

INGREDIENTS AND APPEARANCE

ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE CARAMEL 
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0890
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
DIMETHICONE (UNII: 92RU3N3Y1O)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
BRAZILIAN PEPPER (UNII: SUG822G7CD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE NP (UNII: 4370DF050B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
OCTYLDODECANOL (UNII: 461N1O614Y)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CERESIN (UNII: Q1LS2UJO3A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0890-1	4 g in 1 CARTON; Type 0: Not a Combination Product	06/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/16/2021

Labeler - Ventura Corporation LTD (602751344)

Registrant - BEL STAR S A (880160197)

Establishment
Name	Address	ID/FEI	Business Operations
BEL STAR S A		880160197	manufacture(43596-0890)