Ultra Balm Moisturizing Protective Balm For Lips SPF 20 Nude Caramel: Package Insert and Label Information

ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE CARAMEL- octinoxate and zinc oxide stick
Ventura Corporation LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients Purpose

Octinoxate 7.50% Sunscreen

Zinc Oxide 4.90% Sunscreen

Uses

• Helps prevent sunburn.

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

Stop use and ask a doctor if rash occurs.

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.

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 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 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)

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g in 100 g ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 4.9 g in 100 g

Inactive Ingredients Ingredient Name Strength CHLORPHENESIN FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) POLYGLYCERYL-4 ISOSTEARATE TRIDECYL STEARATE DIMETHICONE LECITHIN, SOYBEAN MICA FERRIC OXIDE RED TALC .ALPHA.-TOCOPHEROL ACETATE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) HELIANTHUS ANNUUS SEED WAX HEXYL LAURATE BRAZILIAN PEPPER PHENOXYETHANOL ACACIA DECURRENS FLOWER WAX MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE TRIDECYL TRIMELLITATE POLYGLYCERIN-3 TRIETHOXYCAPRYLYLSILANE NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE CAPRYLYL GLYCOL CERAMIDE NP TITANIUM DIOXIDE ETHYLHEXYL PALMITATE OCTYLDODECANOL HIGH DENSITY POLYETHYLENE CERESIN SILICON DIOXIDE CARNAUBA WAX

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43596-0890-1 4 g in 1 CARTON None

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	Operations
BEL STAR S A		880160197	manufacture (43596-0890)

Revised: 06/2021 Ventura Corporation LTD