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| Product NDC Code | 14141-454 | ||||
|---|---|---|---|---|---|
| Drug Name | Ultra balm moisturizing protective balm for lips spf 20 rose cotton |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | M020 | ||||
| Labeler Name | BEL STAR S A | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Purpose Octinoxate 7.50%.............Sunscreen Zinc oxide 4.90 %........... Sunscreen
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Stop use and ask a doctor if rash occurs.
Purpose
Information about the drug product’s indications for use.Uses Helps prevent sunburn.
Spl product data elements
Usually a list of ingredients in a drug product.Ultra Balm Moisturizing Protective Balm for lips SPF 20 Coral Petale Octinoxate, Zinc Oxide 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 ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE Ultra Balm Moisturizing Protective Balm for lips SPF 20 Rose Paradise Octinoxate, Zinc Oxide FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE 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 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 ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE Ultra Balm Moisturizing Protective Balm for lips SPF 20 Rose Cotton Octinoxate, Zinc Oxide FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE 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 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 ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Translucide Octinoxate, Zinc Oxide FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE 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 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 ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE Ultra Balm Moisturizing Protective Balm for lips SPF 20 Cerise Brise Octinoxate, Zinc Oxide FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW 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 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 ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Ultra Balm SPF 20 Nude Translucide L'BEL ULTRA BALM Moisturizing Protective Balm for lips SPF 20 Nude Translucide Net. Wt. 0.14 oz (4 g) Nude Translucide
Ultra Balm SPF 20 Coral Petal L'BEL ULTRA BALM Moisturizing Protective Balm for lips SPF 20 Coral Petale Net. Wt. 0.14 oz (4 g) Coral Petale
Ultra Balm SPF 20 Rose Paradise L'BEL ULTRA BALM Moisturizing Protective Balm for lips SPF 20 Rose Paradise Net. Wt. 0.14 oz (4 g) Rose Paradise
Ultra Balm SPF 20 Rose Cotton L'BEL ULTRA BALM Moisturizing Protective Balm for lips SPF 20 Rose Cotton Net. Wt. 0.14 oz (4 g) Rose Cotton
Ultra Balm SPF 20 Cerise Brise L'BEL ULTRA BALM Moisturizing Protective Balm for lips SPF 20 Cerise Brise Net. Wt. 0.14 oz (4 g) Cerise Brise
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Protect the product in this container from excessive heat and direct sun
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API