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| Product NDC Code | 73496-003 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Roc multi correxion 5 in 1 chest, neck and face sunscreen broad spectrum spf 30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | ROC Skincare | ||||||||
| Packages |
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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 For sunscreen use:apply generously and evenly15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun 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 sunglasseschildren under 6 months of age: Ask a doctor INACTIVE INGREDIENTS Water, Propylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Steareth-2, Ethylhexyl Palmitate, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hexylresorcinol, Steareth-21, Ammonium Acryloyldimethyltaurate/VP Copolymer, Behenyl Alcohol, Phenoxyethanol, Dimethicone Crosspolymer, Ascorbyl Glucoside, Sclerotium Gum, Chlorphenesin, Fragrance, Disodium EDTA, Tocopheryl Acetate, Maltodextrin, Ethylhexylglycerin, Sodium Hydroxide, Butylene Glycol, Peucedanum Graveolens (Dill) Extract, Rubus Fruticosus (Blackberry) Leaf Extract, Xanthan Gum QUESTIONS? Call 1-800-RoC-1964 (1-800-762-1964); Outside US, dial collect 215-273-8755, or visit ww.rocskincare.com
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Water, Propylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Steareth-2, Ethylhexyl Palmitate, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hexylresorcinol, Steareth-21, Ammonium Acryloyldimethyltaurate/VP Copolymer, Behenyl Alcohol, Phenoxyethanol, Dimethicone Crosspolymer, Ascorbyl Glucoside, Sclerotium Gum, Chlorphenesin, Fragrance, Disodium EDTA, Tocopheryl Acetate, Maltodextrin, Ethylhexylglycerin, Sodium Hydroxide, Butylene Glycol, Peucedanum Graveolens (Dill) Extract, Rubus Fruticosus (Blackberry) Leaf Extract, Xanthan Gum QUESTIONS? Call 1-800-RoC-1964 (1-800-762-1964); Outside US, dial collect 215-273-8755, or visit ww.rocskincare.com
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 sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun 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 and ask a doctor if rash occurs DIRECTIONS For sunscreen use:apply generously and evenly15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun 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 sunglasseschildren under 6 months of age: Ask a doctor INACTIVE INGREDIENTS Water, Propylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Steareth-2, Ethylhexyl Palmitate, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hexylresorcinol, Steareth-21, Ammonium Acryloyldimethyltaurate/VP Copolymer, Behenyl Alcohol, Phenoxyethanol, Dimethicone Crosspolymer, Ascorbyl Glucoside, Sclerotium Gum, Chlorphenesin, Fragrance, Disodium EDTA, Tocopheryl Acetate, Maltodextrin, Ethylhexylglycerin, Sodium Hydroxide, Butylene Glycol, Peucedanum Graveolens (Dill) Extract, Rubus Fruticosus (Blackberry) Leaf Extract, Xanthan Gum QUESTIONS? Call 1-800-RoC-1964 (1-800-762-1964); Outside US, dial collect 215-273-8755, or visit ww.rocskincare.com
Purpose
Information about the drug product’s indications for use.OTC - PURPOSE Active ingredientsPurpose Avobenzone 2% Sunscreen Homosalate 4% Sunscreen Octisalate 4% Sunscreen Octocrylene 2% Sunscreen OTC - 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 USES Helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun 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 and ask a doctor if rash occurs DIRECTIONS For sunscreen use:apply generously and evenly15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun 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 sunglasseschildren under 6 months of age: Ask a doctor INACTIVE INGREDIENTS Water, Propylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Steareth-2, Ethylhexyl Palmitate, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hexylresorcinol, Steareth-21, Ammonium Acryloyldimethyltaurate/VP Copolymer, Behenyl Alcohol, Phenoxyethanol, Dimethicone Crosspolymer, Ascorbyl Glucoside, Sclerotium Gum, Chlorphenesin, Fragrance, Disodium EDTA, Tocopheryl Acetate, Maltodextrin, Ethylhexylglycerin, Sodium Hydroxide, Butylene Glycol, Peucedanum Graveolens (Dill) Extract, Rubus Fruticosus (Blackberry) Leaf Extract, Xanthan Gum QUESTIONS? Call 1-800-RoC-1964 (1-800-762-1964); Outside US, dial collect 215-273-8755, or visit ww.rocskincare.com
Spl product data elements
Usually a list of ingredients in a drug product.ROC MULTI CORREXION 5 IN 1 CHEST, NECK AND FACE SUNSCREEN BROAD SPECTRUM SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER PROPYLENE GLYCOL GLYCERIN ISONONYL ISONONANOATE DIMETHICONE STEARETH-2 ETHYLHEXYL PALMITATE STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) SHEA BUTTER VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER HEXYLRESORCINOL STEARETH-21 AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER DOCOSANOL PHENOXYETHANOL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) ASCORBYL GLUCOSIDE BETASIZOFIRAN CHLORPHENESIN EDETATE DISODIUM ANHYDROUS MALTODEXTRIN ETHYLHEXYLGLYCERIN SODIUM HYDROXIDE BUTYLENE GLYCOL DILL RUBUS FRUTICOSUS LEAF XANTHAN GUM .ALPHA.-TOCOPHEROL ACETATE, DL-
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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL OTC - PURPOSE Active ingredientsPurpose Avobenzone 2% Sunscreen Homosalate 4% Sunscreen Octisalate 4% Sunscreen Octocrylene 2% Sunscreen OTC - 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 USES Helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun 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 and ask a doctor if rash occurs DIRECTIONS For sunscreen use:apply generously and evenly15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun 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 sunglasseschildren under 6 months of age: Ask a doctor INACTIVE INGREDIENTS Water, Propylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Steareth-2, Ethylhexyl Palmitate, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hexylresorcinol, Steareth-21, Ammonium Acryloyldimethyltaurate/VP Copolymer, Behenyl Alcohol, Phenoxyethanol, Dimethicone Crosspolymer, Ascorbyl Glucoside, Sclerotium Gum, Chlorphenesin, Fragrance, Disodium EDTA, Tocopheryl Acetate, Maltodextrin, Ethylhexylglycerin, Sodium Hydroxide, Butylene Glycol, Peucedanum Graveolens (Dill) Extract, Rubus Fruticosus (Blackberry) Leaf Extract, Xanthan Gum QUESTIONS? Call 1-800-RoC-1964 (1-800-762-1964); Outside US, dial collect 215-273-8755, or visit ww.rocskincare.com ROC MULTI CORREXION 5 IN 1 CHEST, NECK AND FACE SUNSCREEN BROAD SPECTRUM SPF 30.jpg
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.OTC - 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 USES Helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun 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 and ask a doctor if rash occurs DIRECTIONS For sunscreen use:apply generously and evenly15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun 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 sunglasseschildren under 6 months of age: Ask a doctor INACTIVE INGREDIENTS Water, Propylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Steareth-2, Ethylhexyl Palmitate, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hexylresorcinol, Steareth-21, Ammonium Acryloyldimethyltaurate/VP Copolymer, Behenyl Alcohol, Phenoxyethanol, Dimethicone Crosspolymer, Ascorbyl Glucoside, Sclerotium Gum, Chlorphenesin, Fragrance, Disodium EDTA, Tocopheryl Acetate, Maltodextrin, Ethylhexylglycerin, Sodium Hydroxide, Butylene Glycol, Peucedanum Graveolens (Dill) Extract, Rubus Fruticosus (Blackberry) Leaf Extract, Xanthan Gum QUESTIONS? Call 1-800-RoC-1964 (1-800-762-1964); Outside US, dial collect 215-273-8755, or visit ww.rocskincare.com
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? Call 1-800-RoC-1964 (1-800-762-1964); Outside US, dial collect 215-273-8755, or visit ww.rocskincare.com
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 and ask a doctor if rash occurs DIRECTIONS For sunscreen use:apply generously and evenly15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun 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 sunglasseschildren under 6 months of age: Ask a doctor INACTIVE INGREDIENTS Water, Propylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Steareth-2, Ethylhexyl Palmitate, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hexylresorcinol, Steareth-21, Ammonium Acryloyldimethyltaurate/VP Copolymer, Behenyl Alcohol, Phenoxyethanol, Dimethicone Crosspolymer, Ascorbyl Glucoside, Sclerotium Gum, Chlorphenesin, Fragrance, Disodium EDTA, Tocopheryl Acetate, Maltodextrin, Ethylhexylglycerin, Sodium Hydroxide, Butylene Glycol, Peucedanum Graveolens (Dill) Extract, Rubus Fruticosus (Blackberry) Leaf Extract, Xanthan Gum QUESTIONS? Call 1-800-RoC-1964 (1-800-762-1964); Outside US, dial collect 215-273-8755, or visit ww.rocskincare.com
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