Lbel Solutions Pro Hialuron Balm Balsamo Labial Hidratante 72h Fps 20 Hydrating Lip Balm 72h Spf 20

Lbel Solutions Pro Hialuron Balm Balsamo Labial Hidratante 72h Fps 20 Hydrating Lip Balm 72h Spf 20
SPL v2
SPL
SPL Set ID 25b6cb46-6516-376a-e063-6394a90a44f6
Route
TOPICAL
Published
Effective Date 2025-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (49 mg) Octinoxate (75 mg)
Inactive Ingredients
Menthyl Lactate Proline Glycerin Isononyl Isononanoate Luffa Cylindrica Seed Oil Rice Amino Acids Red 40 Lake Propylene Carbonate Benzyl Alcohol Hydrogenated Polycyclopentadiene (580 Wamw) Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Phenoxyethanol Sodium Hyaluronate Tocopherol Stearalkonium Hectorite Polyhydroxystearic Acid (2300 Mw) Hdi/trimethylol Hexyllactone Crosspolymer Hydrogenated Coco-glycerides Chlorphenesin Ci 77491 Polyethylene Shea Butter Hexyl Laurate Glycine Soja (soybean) Seed Silica Dimethyl Silylate Irvingia Gabonensis Kernel Butter Water Ethylhexyl Palmitate Carnauba Wax Polymethylsilsesquioxane (4.5 Microns) Terpineol Pelargonium Graveolens Flower Oil D&c Red No. 6 Titanium Dioxide Isopropyl Titanium Triisostearate Silicon Dioxide Disteardimonium Hectorite Geraniol Hydroxycitronellal Beeswax Ci 77492 Ci 77499 .alpha.-tocopherol Acetate Butyrospermum Parkii (shea) Butter Unsaponifiables Caprylic/capric Triglyceride Caprylyl Glycol Isododecane Polyglyceryl-3 Diisostearate Jojoba Oil Octyldodecanol Sodium Saccharin Dicaprylyl Carbonate Polyglyceryl-4 Isostearate Argan Oil Croton Lechleri Resin Ascorbyl Tetraisopalmitate Hydrolyzed Soy Protein (enzymatic; 2000 Mw) D&c Red No. 7 Triethoxycaprylylsilane Isopropyl Myristate Hydrogenated Polyisobutene (1300 Mw) Diethylhexyl Syringylidenemalonate Ci 42090 Benzyl Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-11
Description

Octinoxate 7.50% Zinc Oxide 4.90%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.50% Zinc Oxide 4.90%

Uses
  • Helps prevent sunburn.
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.
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.
Do Not Use

on damaged or broken skin.

Other Information
  • Protect the product in this container ifrom excessive heat and direct sun.
Active Ingredients

Octinoxate 7.50%

Zinc Oxide 4.90%

Inactive Ingredients

Isononyl isononanoate, hydrogenated polycyclopentadiene, hydrogenated polyisobutene, polyethylene, glycerin, beeswax, butyrospermum parkii (shea) butter extract, isododecane, silica, polyglyceryl-3 diisostearate, simmondsia chinensis (jojoba) seed oil, octyldodecanol, dicaprylyl carbonate, butyrospermum parkii (shea) butter, diethylhexyl syringylidenemalonate, copernicia cerifera (carnauba) wax, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, disteardimonium hectorite, tocopheryl acetate, polymethylsilsesquioxane, menthyl lactate, hexyl laurate, irvingia gabonensis kernel butter, ethylhexyl palmitate, fragrance, glycine soja (soybean) seed extract, hdi/trimethylol hexyllactone crosspolymer, silica dimethyl silylate, butyrospermum parkii (shea) butter unsaponifiables, hydrogenated coco-glycerides, phenoxyethanol, sorbitol/sebacic acid copolymer behenate, argania spinosa kernel oil, sodium hyaluronate, caprylic/capric triglyceride, caprylyl glycol, sodium saccharin, triethoxycaprylylsilane, chlorphenesin, croton lechleri resin extract, luffa cylindrica seed oil, tocopherol, ascorbyl tetraisopalmitate, water, hydrolyzed soy protein, rice amino acids, proline, hydrolyzed adansonia digitata seed extract, geraniol, terpineol, hydroxycitronellal, benzyl alcohol, benzyl benzoate, pelargonium graveolens flower oil.

May contain: Red 40 lake, red 6 lake, red 7 lake, iron oxides, titanium dioxide, isopropyl myristate, blue 1 lake, isopropyl titanium triisostearate, stearalkonium hectorite, polyhydroxystearic acid, propylene carbonate.

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash occurs.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Product Packaging Rose Creme

Product Packaging Cherry Glaze

Product Packaging Nude Universel

Product Packaging Rose Universel

Product Packaging Berry Universel

Product Packaging Coral Universel

Structured Label Content

Uses
  • Helps prevent sunburn.
Purpose

Sunscreen

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.
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.
Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)
  • Protect the product in this container ifrom excessive heat and direct sun.
Active Ingredients (Active ingredients)

Octinoxate 7.50%

Zinc Oxide 4.90%

Inactive Ingredients

Isononyl isononanoate, hydrogenated polycyclopentadiene, hydrogenated polyisobutene, polyethylene, glycerin, beeswax, butyrospermum parkii (shea) butter extract, isododecane, silica, polyglyceryl-3 diisostearate, simmondsia chinensis (jojoba) seed oil, octyldodecanol, dicaprylyl carbonate, butyrospermum parkii (shea) butter, diethylhexyl syringylidenemalonate, copernicia cerifera (carnauba) wax, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, disteardimonium hectorite, tocopheryl acetate, polymethylsilsesquioxane, menthyl lactate, hexyl laurate, irvingia gabonensis kernel butter, ethylhexyl palmitate, fragrance, glycine soja (soybean) seed extract, hdi/trimethylol hexyllactone crosspolymer, silica dimethyl silylate, butyrospermum parkii (shea) butter unsaponifiables, hydrogenated coco-glycerides, phenoxyethanol, sorbitol/sebacic acid copolymer behenate, argania spinosa kernel oil, sodium hyaluronate, caprylic/capric triglyceride, caprylyl glycol, sodium saccharin, triethoxycaprylylsilane, chlorphenesin, croton lechleri resin extract, luffa cylindrica seed oil, tocopherol, ascorbyl tetraisopalmitate, water, hydrolyzed soy protein, rice amino acids, proline, hydrolyzed adansonia digitata seed extract, geraniol, terpineol, hydroxycitronellal, benzyl alcohol, benzyl benzoate, pelargonium graveolens flower oil.

May contain: Red 40 lake, red 6 lake, red 7 lake, iron oxides, titanium dioxide, isopropyl myristate, blue 1 lake, isopropyl titanium triisostearate, stearalkonium hectorite, polyhydroxystearic acid, propylene carbonate.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs.

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.

Product Packaging Rose Creme (Product Packaging - Rose Creme)

Product Packaging Cherry Glaze (Product Packaging - Cherry Glaze)

Product Packaging Nude Universel (Product Packaging - Nude Universel)

Product Packaging Rose Universel (Product Packaging - Rose Universel)

Product Packaging Berry Universel (Product Packaging - Berry Universel)

Product Packaging Coral Universel (Product Packaging - Coral Universel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:35.491684 · Updated: 2026-03-14T23:11:13.760766