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Very emollient body daily shade spf15 - Medication Information

Product NDC Code 61995-0371
Drug Name

Very emollient body daily shade spf15

Type Brand
Active Ingredients
Avobenzone 2 g/100g
Homosalate 7.5 g/100g
Octisalate 5 g/100g
Octocrylene 3 g/100g
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name The Hain Celestial Group
Packages
Package NDC Code Description
61995-0371-1 340 g in 1 bottle, pump (61995-0371-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Avobenzone 2.5% Homosalate 7.5% Octisalate 5.0% Octocrylene 3.0%

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.
For sunscreen use, apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating. Children under 6 months: ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Water (Aqua), Glycerin, Glyceryl Stearate SE, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, Sesamum Indicum (Sesame) Seed Oil, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Vitis Vinifera (Grape) Seed Oil, Aloe Barbadensis Leaf Juice (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Cucumis Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia Extract (1), Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract (1), Ascorbic Acid, Panthenol, Tocopheryl Acetate, Allantoin, Citric Acid, Glycolic Acid, Lactic Acid, Lecithin, Polysorbate 60, Potassium Hydroxide, Xanthan Gum, Alcohol (1), Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Amyl Cinnamal, Benzyl Alcohol, Benzyl Salicylate, Butylphenyl Methylpropional, Coumarin, Geraniol, Hexyl Cinnamal, Limonene, Linalool, Fragrance (Parfum)

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.
For sunscreen use, apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating. Children under 6 months: ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with Broad Spectrum SPF 15 or higher and other protective measures, including: limit time in sun, especially 10am-2pm, and wear long-sleeved shirts, pants, hats and sunglasses.

Purpose

Information about the drug product’s indications for use.
Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
Very Emollient Body Daily Shade SPF15 Avobenzone, Homosalate, Octisalate, Octocrylene POLYSORBATE 60 JOJOBA OIL DEHYDROACETIC ACID LECITHIN, SOYBEAN LACTIC ACID ALCOHOL BUTYLPHENYL METHYLPROPIONAL ECHINACEA ANGUSTIFOLIA SAFFLOWER OIL CETYL ALCOHOL DIMETHICONE 100 ALOE VERA LEAF GREEN TEA LEAF COUMARIN GLYCERYL STEARATE SE BENZYL ALCOHOL HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE LAVANDULA ANGUSTIFOLIA WHOLE SHEA BUTTER HYDROGENATED PALM KERNEL OIL PHENOXYETHANOL XANTHAN GUM GRAPE SEED OIL PANTHENOL GLYCOLIC ACID ALLANTOIN LIMONENE, (+/-)- AVOCADO OIL GLYCERIN WATER SESAME OIL POTASSIUM HYDROXIDE ASCORBIC ACID .ALPHA.-HEXYLCINNAMALDEHYDE, (2E)- .ALPHA.-AMYLCINNAMALDEHYDE GERANIOL LINALOOL, (+/-)- BENZYL SALICYLATE SALICYLIC ACID MATRICARIA CHAMOMILLA CUCUMBER POTASSIUM SORBATE SODIUM BENZOATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE White to pale off-white

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.
PDP

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.

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.
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 skin 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