Ultra Balm Moisturizing Protective Balm For Lips Spf 20

SPL v4

SPL

SPL Set ID c4d56723-3953-fb8e-e053-2a95a90a69d3

Route

TOPICAL

Published

Effective Date 2021-06-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (4.9 g) Octinoxate (7.5 g)

Inactive Ingredients

Brazilian Pepper Chlorphenesin Neopentyl Glycol Dicaprylate/dicaprate Octyldodecanol Carnauba Wax Cetyl Peg/ppg-10/1 Dimethicone (hlb 1.5) .alpha.-tocopherol Acetate Helianthus Annuus Seed Wax Hexyl Laurate Acacia Decurrens Flower Wax Ethylhexyl Palmitate Dipentaerythrityl Hexacaprylate/hexacaprate Tridecyl Trimellitate Polyglyceryl-4 Isostearate Ceresin Silicon Dioxide Ferrosoferric Oxide Ferric Oxide Yellow High Density Polyethylene Triethoxycaprylylsilane Polyglycerin-3 Phenoxyethanol Tridecyl Stearate Dimethicone Caprylyl Glycol Trimethylsiloxysilicate (m/q 0.6-0.8) Ceramide Np Lecithin, Soybean Mica Titanium Dioxide Magnesium Potassium Aluminosilicate Fluoride Ferric Oxide Red Talc

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-06-15

Description

Active Ingredients Purpose Octinoxate 7.50%.............Sunscreen Zinc oxide 4.90 %........... Sunscreen

Medication Information

Warnings and Precautions

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 useon damaged or broken skin.
When using this productkeep out of eyes. Rinse with water to remove.

Indications and Usage

Stop use and ask a doctor ifrash 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 Coral Petal

Ultra Balm Spf 20 Rose Cotton

Ultra Balm Spf 20 Cerise Brise

Ultra Balm Spf 20 Rose Paradise

Ultra Balm Spf 20 Nude Translucide

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor ifrash 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)

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 useon damaged or broken skin.
When using this productkeep 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)

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 Coral Petal (Ultra Balm SPF 20 Coral Petal)

Ultra Balm Spf 20 Rose Cotton (Ultra Balm SPF 20 Rose Cotton)

Ultra Balm Spf 20 Cerise Brise (Ultra Balm SPF 20 Cerise Brise)

Ultra Balm Spf 20 Rose Paradise (Ultra Balm SPF 20 Rose Paradise)

Ultra Balm Spf 20 Nude Translucide (Ultra Balm SPF 20 Nude Translucide)

Advanced Ingredient Data

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{"34067-9": "Stop use and ask a doctor if rash occurs.", "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", "34071-1": "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.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "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.", "55105-1": "Uses Helps prevent sunburn.", "55106-9": "Active Ingredients Purpose Octinoxate 7.50%.............Sunscreen Zinc oxide 4.90 %........... Sunscreen", "60561-8": "Other Information Protect the product in this container from excessive heat and direct sun"}

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Source: dailymed · Ingested: 2026-02-15T12:06:20.952132 · Updated: 2026-03-14T23:09:05.302478