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| Product NDC Code | 68828-515 | ||||||||
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| Drug Name | Revitalize solar protection fluid broad spectrum spf 50 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Jafra cosmetics International | ||||||||
| 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 Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 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 generously and evenly 15 minutes before sun exposure use a water-resistant sunscreen if swimming or sweating reapply at least every 2 hours. 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 your 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/Aqua, Styrene/Acrylates Copolymer, Aluminum Starch Octenylsuccinate, Ethylhexylglycerin, Benzyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Bisabolol, Behenyl Alcohol, Cyclopentasiloxane, Lauroyl Lysine, Arachidyl Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Arginine, Chlorphenesin, Disodium EDTA, Acrylates/Dimethicone Copolymer, Royal Jelly Powder, Glycerin, Butyrospermum Parkii (Shea) Butter, Dipropylene Glycol, Sodium Ascorbyl Phosphate, Lecithin, Hydrogenated Lecithin, Royal Jelly, Polygonum Aviculare Extract, Phenethyl Alcohol, Cocos Nucifera (Coconut) Fruit Extract, Butylene Glycol, Actinidia Chinensis (Kiwi) Fruit Water, Moringa Oleifera Leaf Extract, Maltodextrin, Tetrapeptide-45, Alcohol, Sophora Flavescens Root Extract, Fragrance/Parfum, Benzyl Salicylate, Butylphenyl Methylpropional, Hydroxycitronellal, Limonene, Linalool
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 If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
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.Jafra Royal Defy Sample Kit Avobenzone, Homosalate, Octisalate, Octocrylene Gentle Cleansing milk WATER COCAMIDOPROPYL BETAINE PEG-7 GLYCERYL COCOATE COCO GLUCOSIDE DECYL GLUCOSIDE STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) SODIUM LAUROYL SARCOSINATE GLYCOL STEARATE PHENOXYETHANOL SODIUM HYDROXIDE ALLANTOIN EDETATE SODIUM BENZOIC ACID DEHYDROACETIC ACID CAPRYLYL GLYCOL SODIUM ASCORBYL PHOSPHATE GLYCERIN POLYGONUM AVICULARE TOP ROYAL JELLY SHEA BUTTER DIPROPYLENE GLYCOL LECITHIN, SOYBEAN HYDROGENATED SOYBEAN LECITHIN PHENYLETHYL ALCOHOL ETHYLHEXYLGLYCERIN MALTODEXTRIN BENZYL SALICYLATE Spot Serum WATER OCTYLDODECANOL BIOSACCHARIDE GUM-1 SODIUM POLYACRYLATE (2500000 MW) BUTYLENE GLYCOL KIWI FRUIT OIL DMDM HYDANTOIN COCONUT EDETATE TRISODIUM SODIUM ASCORBYL PHOSPHATE MORINGA OLEIFERA LEAF ALCOHOL SOPHORA FLAVESCENS ROOT LECITHIN, SOYBEAN PHENOXYETHANOL SHEA BUTTER IODOPROPYNYL BUTYLCARBAMATE DIPROPYLENE GLYCOL GARDEN CRESS SPROUT HYDROGENATED SOYBEAN LECITHIN PHENYLETHYL ALCOHOL ROYAL JELLY ETHYLHEXYLGLYCERIN MALTODEXTRIN BENZYL SALICYLATE BUTYLPHENYL METHYLPROPIONAL HYDROXYCITRONELLAL LIMONENE, (+)- Longevity Creme WATER POLYISOBUTYLENE (800000 MW) CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER ISOPROPYL PALMITATE ALKYL (C12-15) BENZOATE DIMETHICONE PENTYLENE GLYCOL DI-PPG-3 MYRISTYL ETHER ADIPATE STEARYL STEARATE PENTAERYTHRITYL DISTEARATE ROYAL JELLY HONEY HYDROGENATED SOYBEAN LECITHIN SHEA BUTTER SODIUM PYRROLIDONE CARBOXYLATE MYRISTYL MYRISTATE PALMITOYL GLYCINE PHENYLETHYL ALCOHOL ETHYLHEXYLGLYCERIN MALTODEXTRIN SQUALENE COCONUT OIL TROLAMINE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) EDETATE TRISODIUM PEG-4 LAURATE IODOPROPYNYL BUTYLCARBAMATE LECITHIN, SOYBEAN DIPROPYLENE GLYCOL DMDM HYDANTOIN VITAMIN A PALMITATE ASCORBYL PALMITATE .ALPHA.-TOCOPHEROL ACETATE BENZYL SALICYLATE LIMONENE, (+)- HYDROXYCITRONELLOL BUTYLPHENYL METHYLPROPIONAL LINALOOL, (+/-)- Revitalize Solar Protection Fluid Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) KIWI FRUIT OIL ALCOHOL ALLANTOIN ALUMINUM STARCH OCTENYLSUCCINATE ARACHIDYL ALCOHOL ARACHIDYL GLUCOSIDE ARGININE DOCOSANOL BENZYL ALCOHOL LEVOMENOL BUTYLENE GLYCOL SHEA BUTTER CHLORPHENESIN COCONUT CYCLOMETHICONE 5 DIPROPYLENE GLYCOL EDETATE DISODIUM ANHYDROUS ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL MONOSTEARATE HYDROGENATED SOYBEAN LECITHIN LAUROYL LYSINE LECITHIN, SOYBEAN MALTODEXTRIN MORINGA OLEIFERA LEAF PEG-100 STEARATE PHENYLETHYL ALCOHOL POLYGONUM AVICULARE TOP ROYAL JELLY SODIUM ASCORBYL PHOSPHATE SOPHORA FLAVESCENS ROOT STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) WATER BENZYL SALICYLATE BUTYLPHENYL METHYLPROPIONAL HYDROXYCITRONELLAL LIMONENE, (+)- LINALOOL, (+/-)- AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE Revitalize Solar Protection Fluid Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) KIWI FRUIT OIL ALCOHOL ALLANTOIN ALUMINUM STARCH OCTENYLSUCCINATE ARACHIDYL ALCOHOL ARACHIDYL GLUCOSIDE ARGININE DOCOSANOL BENZYL ALCOHOL LEVOMENOL BUTYLENE GLYCOL SHEA BUTTER CHLORPHENESIN COCONUT CYCLOMETHICONE 5 DIPROPYLENE GLYCOL EDETATE DISODIUM ANHYDROUS ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL MONOSTEARATE HYDROGENATED SOYBEAN LECITHIN LAUROYL LYSINE LECITHIN, SOYBEAN MALTODEXTRIN MORINGA OLEIFERA LEAF PEG-100 STEARATE PHENYLETHYL ALCOHOL POLYGONUM AVICULARE TOP ROYAL JELLY SODIUM ASCORBYL PHOSPHATE SOPHORA FLAVESCENS ROOT STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) WATER BENZYL SALICYLATE BUTYLPHENYL METHYLPROPIONAL HYDROXYCITRONELLAL LIMONENE, (+)- LINALOOL, (+/-)- AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE Jafra Royal Defy Travel Kit Avobenzone, Homosalate, Octisalate, Octocrylene Gentle Cleansing milk WATER COCAMIDOPROPYL BETAINE PEG-7 GLYCERYL COCOATE COCO GLUCOSIDE DECYL GLUCOSIDE STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) SODIUM LAUROYL SARCOSINATE GLYCOL STEARATE PHENOXYETHANOL SODIUM HYDROXIDE ALLANTOIN EDETATE SODIUM BENZOIC ACID DEHYDROACETIC ACID CAPRYLYL GLYCOL SODIUM ASCORBYL PHOSPHATE GLYCERIN POLYGONUM AVICULARE TOP ROYAL JELLY SHEA BUTTER DIPROPYLENE GLYCOL LECITHIN, SOYBEAN HYDROGENATED SOYBEAN LECITHIN PHENYLETHYL ALCOHOL ETHYLHEXYLGLYCERIN MALTODEXTRIN BENZYL SALICYLATE Spot Serum WATER OCTYLDODECANOL BIOSACCHARIDE GUM-1 SODIUM POLYACRYLATE (2500000 MW) BUTYLENE GLYCOL ROYAL JELLY KIWI FRUIT OIL DMDM HYDANTOIN COCONUT EDETATE TRISODIUM SODIUM ASCORBYL PHOSPHATE MORINGA OLEIFERA LEAF ALCOHOL SOPHORA FLAVESCENS ROOT LECITHIN, SOYBEAN PHENOXYETHANOL SHEA BUTTER IODOPROPYNYL BUTYLCARBAMATE DIPROPYLENE GLYCOL GARDEN CRESS SPROUT HYDROGENATED SOYBEAN LECITHIN PHENYLETHYL ALCOHOL ETHYLHEXYLGLYCERIN MALTODEXTRIN BENZYL SALICYLATE BUTYLPHENYL METHYLPROPIONAL HYDROXYCITRONELLAL LIMONENE, (+)- Longevity Creme WATER POLYISOBUTYLENE (800000 MW) CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER ISOPROPYL PALMITATE ALKYL (C12-15) BENZOATE DIMETHICONE PENTYLENE GLYCOL DI-PPG-3 MYRISTYL ETHER ADIPATE STEARYL STEARATE PENTAERYTHRITYL DISTEARATE ROYAL JELLY HONEY HYDROGENATED SOYBEAN LECITHIN SHEA BUTTER SODIUM PYRROLIDONE CARBOXYLATE MYRISTYL MYRISTATE PALMITOYL GLYCINE PHENYLETHYL ALCOHOL ETHYLHEXYLGLYCERIN MALTODEXTRIN SQUALENE COCONUT OIL TROLAMINE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) EDETATE TRISODIUM PEG-4 LAURATE IODOPROPYNYL BUTYLCARBAMATE LECITHIN, SOYBEAN DIPROPYLENE GLYCOL DMDM HYDANTOIN VITAMIN A PALMITATE ASCORBYL PALMITATE .ALPHA.-TOCOPHEROL ACETATE BENZYL SALICYLATE LIMONENE, (+)- HYDROXYCITRONELLOL BUTYLPHENYL METHYLPROPIONAL LINALOOL, (+/-)- Revitalize Solar Protection Fluid Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) KIWI FRUIT OIL ALCOHOL ALLANTOIN ALUMINUM STARCH OCTENYLSUCCINATE ARACHIDYL ALCOHOL ARACHIDYL GLUCOSIDE ARGININE DOCOSANOL BENZYL ALCOHOL LEVOMENOL BUTYLENE GLYCOL SHEA BUTTER CHLORPHENESIN COCONUT CYCLOMETHICONE 5 DIPROPYLENE GLYCOL EDETATE DISODIUM ANHYDROUS ETHYLHEXYLGLYCERIN GLYCERIN HYDROGENATED SOYBEAN LECITHIN LAUROYL LYSINE LECITHIN, SOYBEAN MALTODEXTRIN MORINGA OLEIFERA LEAF PEG-100 STEARATE PHENYLETHYL ALCOHOL POLYGONUM AVICULARE TOP ROYAL JELLY SODIUM ASCORBYL PHOSPHATE SOPHORA FLAVESCENS ROOT STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) WATER BENZYL SALICYLATE BUTYLPHENYL METHYLPROPIONAL HYDROXYCITRONELLAL LIMONENE, (+)- LINALOOL, (+/-)- GLYCERYL MONOSTEARATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE
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.Product label image description image description image description
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 this product 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 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
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