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| Product NDC Code | 82109-125 | ||||
|---|---|---|---|---|---|
| Drug Name | Positive light tinted moisturizer broad spectrum spf 20 sunscreen 12c |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Rare Beauty, LLC | ||||
| 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 Homosalate 6.5% Zinc Oxide 5.7%
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. Children under 6 months of age: Ask a doctor. Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Dimethicone, Talc, Isododecane, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Isopentyldiol, Sorbitol, Tocopheryl Acetate, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Chloride, Phenoxyethanol, Magnesium Sulfate, Sodium Dehydroacetate, Benzoic Acid, Hydrogen Dimethicone, Triethoxycaprylylsilane, Disteardimonium Hectorite, Potassium Sorbate, Aluminum Hydroxide, Dehydroacetic Acid, Lecithin, Propylene Carbonate, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Ascorbyl Palmitate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Citric Acid, Gardenia Florida Fruit Extract, Nelumbo Nucifera Flower Extract, Nymphaea Odorata Root Extract, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).
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.Uses Helps prevent sunburn
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 20W Homosalate, Zinc Oxide ISOPENTYLDIOL PHENOXYETHANOL SODIUM CHLORIDE HYDROGEN DIMETHICONE (20 CST) POTASSIUM SORBATE BENZOIC ACID HOMOSALATE HOMOSALATE ZINC OXIDE ZINC OXIDE WATER DEHYDROACETIC ACID TOCOPHEROL ETHYLHEXYLGLYCERIN ASCORBYL PALMITATE CITRIC ACID MONOHYDRATE GARDENIA JASMINOIDES FRUIT NYMPHAEA ODORATA ROOT FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TALC ISODODECANE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) LECITHIN, SOYBEAN TRIETHOXYCAPRYLYLSILANE ALKYL (C12-15) BENZOATE .ALPHA.-TOCOPHEROL ACETATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) MAGNESIUM SULFATE, UNSPECIFIED SODIUM DEHYDROACETATE SUNFLOWER OIL NELUMBO NUCIFERA FLOWER FERRIC OXIDE RED DIMETHICONE DISTEARDIMONIUM HECTORITE ALUMINUM HYDROXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PROPYLENE CARBONATE SORBITOL Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N Homosalate, Zinc Oxide ISOPENTYLDIOL PHENOXYETHANOL SODIUM CHLORIDE HYDROGEN DIMETHICONE (20 CST) POTASSIUM SORBATE BENZOIC ACID HOMOSALATE HOMOSALATE ZINC OXIDE ZINC OXIDE WATER DEHYDROACETIC ACID TOCOPHEROL ETHYLHEXYLGLYCERIN ASCORBYL PALMITATE CITRIC ACID MONOHYDRATE GARDENIA JASMINOIDES FRUIT NYMPHAEA ODORATA ROOT FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TALC ISODODECANE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) LECITHIN, SOYBEAN TRIETHOXYCAPRYLYLSILANE ALKYL (C12-15) BENZOATE .ALPHA.-TOCOPHEROL ACETATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) MAGNESIUM SULFATE, UNSPECIFIED SODIUM DEHYDROACETATE SUNFLOWER OIL NELUMBO NUCIFERA FLOWER FERRIC OXIDE RED DIMETHICONE DISTEARDIMONIUM HECTORITE ALUMINUM HYDROXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PROPYLENE CARBONATE SORBITOL Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 12C Homosalate, Zinc Oxide .ALPHA.-TOCOPHEROL ACETATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) MAGNESIUM SULFATE, UNSPECIFIED SODIUM DEHYDROACETATE SUNFLOWER OIL NELUMBO NUCIFERA FLOWER FERRIC OXIDE RED DIMETHICONE DISTEARDIMONIUM HECTORITE ALUMINUM HYDROXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PROPYLENE CARBONATE SORBITOL ALKYL (C12-15) BENZOATE ISOPENTYLDIOL PHENOXYETHANOL SODIUM CHLORIDE HYDROGEN DIMETHICONE (20 CST) POTASSIUM SORBATE BENZOIC ACID HOMOSALATE HOMOSALATE ZINC OXIDE ZINC OXIDE WATER DEHYDROACETIC ACID TOCOPHEROL ETHYLHEXYLGLYCERIN ASCORBYL PALMITATE CITRIC ACID MONOHYDRATE GARDENIA JASMINOIDES FRUIT NYMPHAEA ODORATA ROOT FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TALC ISODODECANE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) LECITHIN, SOYBEAN TRIETHOXYCAPRYLYLSILANE Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 24N Homosalate, Zinc Oxide PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PROPYLENE CARBONATE SORBITOL ISOPENTYLDIOL PHENOXYETHANOL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) MAGNESIUM SULFATE, UNSPECIFIED SODIUM DEHYDROACETATE SODIUM CHLORIDE SUNFLOWER OIL NELUMBO NUCIFERA FLOWER FERRIC OXIDE RED DIMETHICONE DISTEARDIMONIUM HECTORITE ALUMINUM HYDROXIDE HYDROGEN DIMETHICONE (20 CST) POTASSIUM SORBATE BENZOIC ACID HOMOSALATE HOMOSALATE ZINC OXIDE ZINC OXIDE WATER DEHYDROACETIC ACID TOCOPHEROL ETHYLHEXYLGLYCERIN ASCORBYL PALMITATE CITRIC ACID MONOHYDRATE GARDENIA JASMINOIDES FRUIT NYMPHAEA ODORATA ROOT FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TALC ISODODECANE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) LECITHIN, SOYBEAN TRIETHOXYCAPRYLYLSILANE ALKYL (C12-15) BENZOATE .ALPHA.-TOCOPHEROL ACETATE Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 14W Homosalate, Zinc Oxide ISOPENTYLDIOL PHENOXYETHANOL SODIUM CHLORIDE HYDROGEN DIMETHICONE (20 CST) POTASSIUM SORBATE BENZOIC ACID HOMOSALATE HOMOSALATE ZINC OXIDE ZINC OXIDE WATER DEHYDROACETIC ACID TOCOPHEROL ETHYLHEXYLGLYCERIN ASCORBYL PALMITATE CITRIC ACID MONOHYDRATE GARDENIA JASMINOIDES FRUIT NYMPHAEA ODORATA ROOT FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TALC ISODODECANE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) LECITHIN, SOYBEAN TRIETHOXYCAPRYLYLSILANE ALKYL (C12-15) BENZOATE .ALPHA.-TOCOPHEROL ACETATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) MAGNESIUM SULFATE, UNSPECIFIED SODIUM DEHYDROACETATE SUNFLOWER OIL NELUMBO NUCIFERA FLOWER FERRIC OXIDE RED DIMETHICONE DISTEARDIMONIUM HECTORITE ALUMINUM HYDROXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PROPYLENE CARBONATE SORBITOL Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 22W Homosalate, Zinc Oxide DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) MAGNESIUM SULFATE, UNSPECIFIED SODIUM DEHYDROACETATE SUNFLOWER OIL NELUMBO NUCIFERA FLOWER FERRIC OXIDE RED DIMETHICONE DISTEARDIMONIUM HECTORITE ALUMINUM HYDROXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PROPYLENE CARBONATE SORBITOL ISOPENTYLDIOL PHENOXYETHANOL SODIUM CHLORIDE HYDROGEN DIMETHICONE (20 CST) POTASSIUM SORBATE BENZOIC ACID HOMOSALATE HOMOSALATE ZINC OXIDE ZINC OXIDE WATER DEHYDROACETIC ACID TOCOPHEROL ETHYLHEXYLGLYCERIN ASCORBYL PALMITATE CITRIC ACID MONOHYDRATE GARDENIA JASMINOIDES FRUIT NYMPHAEA ODORATA ROOT FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TALC ISODODECANE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) LECITHIN, SOYBEAN TRIETHOXYCAPRYLYLSILANE ALKYL (C12-15) BENZOATE .ALPHA.-TOCOPHEROL ACETATE Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 16C Homosalate, Zinc Oxide TOCOPHEROL ETHYLHEXYLGLYCERIN ASCORBYL PALMITATE CITRIC ACID MONOHYDRATE GARDENIA JASMINOIDES FRUIT NYMPHAEA ODORATA ROOT FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TALC ISODODECANE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) LECITHIN, SOYBEAN TRIETHOXYCAPRYLYLSILANE ALKYL (C12-15) BENZOATE .ALPHA.-TOCOPHEROL ACETATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) MAGNESIUM SULFATE, UNSPECIFIED SODIUM DEHYDROACETATE SUNFLOWER OIL NELUMBO NUCIFERA FLOWER FERRIC OXIDE RED DIMETHICONE DISTEARDIMONIUM HECTORITE ALUMINUM HYDROXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PROPYLENE CARBONATE SORBITOL ISOPENTYLDIOL PHENOXYETHANOL SODIUM CHLORIDE HYDROGEN DIMETHICONE (20 CST) POTASSIUM SORBATE BENZOIC ACID HOMOSALATE HOMOSALATE ZINC OXIDE ZINC OXIDE WATER DEHYDROACETIC ACID Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 26W Homosalate, Zinc Oxide PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PROPYLENE CARBONATE SORBITOL ISOPENTYLDIOL PHENOXYETHANOL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) MAGNESIUM SULFATE, UNSPECIFIED SODIUM DEHYDROACETATE SODIUM CHLORIDE SUNFLOWER OIL NELUMBO NUCIFERA FLOWER FERRIC OXIDE RED DIMETHICONE DISTEARDIMONIUM HECTORITE ALUMINUM HYDROXIDE HYDROGEN DIMETHICONE (20 CST) POTASSIUM SORBATE WATER BENZOIC ACID HOMOSALATE HOMOSALATE ZINC OXIDE ZINC OXIDE DEHYDROACETIC ACID TOCOPHEROL ETHYLHEXYLGLYCERIN ASCORBYL PALMITATE CITRIC ACID MONOHYDRATE GARDENIA JASMINOIDES FRUIT NYMPHAEA ODORATA ROOT FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TALC ISODODECANE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) LECITHIN, SOYBEAN TRIETHOXYCAPRYLYLSILANE .ALPHA.-TOCOPHEROL ACETATE ALKYL (C12-15) BENZOATE
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.10N 1
12C 1
14W 1
16C 1
20W 1
22W 1
24N 1
26W 1
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Company Information Dist. By Rare Beauty, LLC El Segundo, CA 90245 Made in Italy www.rarebeauty.com
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
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 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-888-892-7273 Monday-Friday, 7am-4pm PST
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use if irritation occurs and ask a doctor if a rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove.
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 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. Stop use if irritation occurs and ask a doctor if a rash occurs. Keep out of reach of children. If swallowed, get medical help right away.
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