Ultra Balm Moisturizing Protective Balm For Lips Spf 20 Nude Caramel

Ultra Balm Moisturizing Protective Balm For Lips Spf 20 Nude Caramel
SPL v1
SPL
SPL Set ID c5fe42e2-0807-87ee-e053-2a95a90a02f1
Route
TOPICAL
Published
Effective Date 2021-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Zinc Oxide (4.9 g)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-06-16
Description

Active Ingredients Purpose Octinoxate 7.50% Sunscreen Zinc Oxide 4.90% Sunscreen

Medication Information

Warnings and Precautions

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.

Indications and Usage

Stop use and ask a doctor if rash occurs.

Dosage and 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
Description

Active Ingredients Purpose Octinoxate 7.50% Sunscreen Zinc Oxide 4.90% Sunscreen

Section 50565-1

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

Section 51727-6

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.

Section 55105-1

Uses

  • Helps prevent sunburn.
Section 55106-9

Active Ingredients Purpose

Octinoxate 7.50% Sunscreen

Zinc Oxide 4.90% Sunscreen

Section 60561-8

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)

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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.

Section 55105-1 (55105-1)

Uses

  • Helps prevent sunburn.
Section 55106-9 (55106-9)

Active Ingredients Purpose

Octinoxate 7.50% Sunscreen

Zinc Oxide 4.90% Sunscreen

Section 60561-8 (60561-8)

Other information

  • Protect the product in this container from excessive heat and direct sun
Ultra Balm Spf 20 Nude Caramel (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:36.507659 · Updated: 2026-03-14T22:59:41.656939