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H.e.b solutions sunscreen - Prescription Drug Labeling

Product NDC Code 37808-959
Drug Name

H.e.b solutions sunscreen

Type Brand
Active Ingredients
Avobenzone 30 mg/ml
Homosalate 100 mg/ml
Octisalate 30 mg/ml
Octocrylene 70 mg/ml
Oxybenzone 60 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name H.E.B
Packages
Package NDC Code Description
37808-959-09 89 ml in 1 tube (37808-959-09)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Acobenzone 3.0%, Homosalate 10.0%, Octisalate 3.0%, Octocrylene 7.0%, Oxybenzone 6.0%

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 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 aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10am-2pm • wear long-sleeve shirts, pants, hats, and sunglasses.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient(s) water, propylene glycol, silica, aluminum starch octenylsuccinate, behenyl alcohol, butylated PVP, glyceryl stearate, microcrystalline cellulose, benzyl alcohol, palmitic acid, myristyl alcohol, stearic acid, saccharomyces/podophyllum peltatum ferment filtrate, lauryl alcohol, cetyl alcohol, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, tocopherol (vitamin E), lecithin, bisabolol, cellulose gum, chlorphenesin, disodium EDTA, butylene glycol

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.
H.E.B Solutions Sunscreen Face SPF 70 Lotion AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE OXYBENZONE OXYBENZONE WATER PROPYLENE GLYCOL SILICON DIOXIDE ALUMINUM STARCH OCTENYLSUCCINATE DOCOSANOL GLYCERYL MONOSTEARATE MICROCRYSTALLINE CELLULOSE BENZYL ALCOHOL PALMITIC ACID MYRISTYL ALCOHOL STEARIC ACID LAURYL ALCOHOL CETYL ALCOHOL ALOE VERA LEAF CHAMOMILE TOCOPHEROL LECITHIN, SOYBEAN CARBOXYMETHYLCELLULOSE SODIUM CHLORPHENESIN EDETATE DISODIUM BUTYLENE GLYCOL LEVOMENOL

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.
H.E.B Solutions Sunscreen Face SPF 70 Lotion 3 FL OZ (89mL) NDC 37808-959-09 Label

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Stop use and ask doctor if • rash occurs

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.

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 may stain or damage some fabrics, materials or surfaces

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or Comments? Call toll free 1-800-527-7731

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

Disclaimer: Do not rely on openFDA 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