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Aveeno protect plus soothe face mineral sunscreen spf 30 - Medication Information

Product NDC Code 69968-0786
Drug Name

Aveeno protect plus soothe face mineral sunscreen spf 30

Type Brand
Active Ingredients
Titanium dioxide 66 mg/ml
Zinc oxide 180 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name Johnson & Johnson Consumer Inc.
Packages
Package NDC Code Description
69968-0786-2 1 tube in 1 carton (69968-0786-2) / 50 ml in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Purpose Titanium Dioxide (6.6%) Sunscreen Zinc Oxide (18%) Sunscreen
Active ingredientsPurpose
Titanium Dioxide (6.6%)Sunscreen
Zinc Oxide (18%)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 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 children under 6 months of age: Ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, Isohexadecane, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Dimethicone, Ethylhexyl methoxycrylene, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, Calcium Aluminum Borosilicate, VP/Hexadecene Copolymer, Styrene/Acrylates Copolymer, Triethoxycaprylylsilane, Aluminum Hydroxide, Xanthan Gum, Stearic Acid, Trisiloxane, Polyester-7, Phenoxyethanol, Polyhydroxystearic Acid, Caprylyl Glycol, Ethylhexylglycerin, Neopentyl Glycol Diheptanoate, Behenyl Alcohol, Glycerin, Disodium EDTA, Silica, Tocopheryl Acetate, Avena Sativa (Oat) Kernel Extract

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.
Active ingredients Purpose Titanium Dioxide (6.6%) Sunscreen Zinc Oxide (18%) Sunscreen
Active ingredientsPurpose
Titanium Dioxide (6.6%)Sunscreen
Zinc Oxide (18%)Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
Aveeno Protect Plus Soothe Face Mineral Sunscreen SPF 30 Titanium Dioxide, Zinc Oxide OAT TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER ETHYLHEXYL METHOXYCRYLENE CAPRYLYL TRISILOXANE BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER TRIETHOXYCAPRYLYLSILANE ALUMINUM HYDROXIDE GLYCERYL MONOSTEARATE PEG-100 STEARATE VINYLPYRROLIDONE/HEXADECENE COPOLYMER XANTHAN GUM TRISILOXANE ISOHEXADECANE BUTYLOCTYL SALICYLATE ALKYL (C12-15) BENZOATE STEARIC ACID ETHYLHEXYLGLYCERIN NEOPENTYL GLYCOL DIHEPTANOATE DOCOSANOL EDETATE DISODIUM ANHYDROUS .ALPHA.-TOCOPHEROL ACETATE CALCIUM ALUMINUM BOROSILICATE DIMETHICONE POLYESTER-7 PHENOXYETHANOL CAPRYLYL GLYCOL GLYCERIN SILICON DIOXIDE

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.
PRINCIPAL DISPLAY PANEL - 50mL Carton Label New! Aveeno® DERMATOLOGIST RECOMMENDED BRAND SOOTHING OAT Protect + Soothe FACE MINERAL SUNSCREEN Broad Spectrum SPF 30 SENSITIVE SKIN Naturally-sourced 100% mineral actives Water resistant (80 min) SPF 30 1.7 fl. oz (50 mL) Aveeno_001

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 Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

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 or contact a Poison Control Center right away

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

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 and ask a doctor if 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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information protect this product from excessive heat and direct sun may stain some fabrics

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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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