OCTINOXATE, ZINC OXIDE

Manufacturer
BEL STAR S A
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:48

Label at a glance#

ProductLBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 NUDE UNIVERSEL
Active ingredientZINC OXIDE, OCTINOXATE
Label structure13 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.50%

Zinc Oxide 4.90%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

  • 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

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Other information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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.

Product Packaging - Berry Universel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging - Coral Universel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

Product Packaging - Nude Universel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33

Product Packaging - Rose Universel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

Product Packaging - Cherry Glaze

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55

Product Packaging - Rose Creme

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

66

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-350-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSEL2 g in 1 TUBESTICK22
14141-350-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSEL1 in 1 BOXSTICK12
14141-351-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 CORAL UNIVERSEL1 in 1 BOXSTICK12
14141-351-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 CORAL UNIVERSEL2 g in 1 TUBESTICK22
14141-352-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 NUDE UNIVERSEL2 g in 1 TUBESTICK22
14141-352-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 NUDE UNIVERSEL1 in 1 BOXSTICK12
14141-353-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 ROSE UNIVERSEL2 g in 1 TUBESTICK22
14141-353-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 ROSE UNIVERSEL1 in 1 BOXSTICK12
14141-463-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 CHERRY GLAZE2 g in 1 TUBESTICK22
14141-463-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 CHERRY GLAZE1 in 1 BOXSTICK12
14141-464-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 ROSE CREME2 g in 1 TUBESTICK22
14141-464-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 ROSE CREME1 in 1 BOXSTICK12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 73 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 10 · 396 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSELOCTINOXATE, ZINC OXIDEBEL STAR S A25b6cb46-6516-376a-e063-6394a90a44f62025-12-03WarningsExact identifier
ndc (package): 14141-351-01
ndc (package): 14141-464-01
ndc (package): 14141-352-01
ndc (package): 14141-463-01
ndc (package): 14141-353-01
ndc (package): 14141-350-01
ndc (product): 14141-463
ndc (product): 14141-352
ndc (product): 14141-350
ndc (product): 14141-353
ndc (product): 14141-351
ndc (product): 14141-464
ndc11 (package): 14141035301
ndc11 (package): 14141035001
ndc11 (package): 14141046401
ndc11 (package): 14141035101
ndc11 (package): 14141035201
ndc11 (package): 14141046301
spl id: 45100706-59a2-05c5-e063-6294a90abf9f
spl set id: 25b6cb46-6516-376a-e063-6394a90a44f6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.