Vaseline
FDA Label NDC 64942-1190

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Conopco Inc. D/b/a Unilever for the product Vaseline (NDC 64942-1190). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredients
Avobenzone (2.0%), Ensulizole (1.5%), Octisalate (5.0%), Octocrylene (1.3%)

Otc - Purpose

Purpose:
Sunscreen

Indications & Usage

Uses
∙ helps prevent sunburn
∙ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

Warnings
For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this productkeep out of eyes rinse with water to remove

Otc - Stop Use

Stop Use and ask a doctor if · rash occurs

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.

Directions

∙ apply generously and evenly 15 minutes before sun exposure.

∙ children under 6 months of age: Ask a doctor

∙ reapply at least every two hours

∙ use a water resistant sunscreen if swimming or sweating

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 am - 2 pm

∙ Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredient

Inactive Ingredients
Water (Aqua), Glycerin, Stearic Acid, Glycol Stearate, PEG-100 Stearate, Dimethicone, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Dihydroxypropyltrimonium Chloride,Tocopheryl Acetate, Phenoxyethanol, Glyceryl Stearate, Potassium Stearate, Carbomer, Cetyl Alcohol, Caprylyl Glycol, Xanthan Gum,Fragrance (Parfum), Disodium EDTA, BHT, Stearamide AMP, Methylisothiazolinone.

Otc - Questions

1-800-457-7084

Package Label.Principal Display Panel

PDP 20.3 fl. oz.

Vaseline Total Moisture Aloe Spf 15 Pdp (Vtmaloespf15pdp)

Vaseline Total Moisture Aloe Spf 15 Pdp (Vtmaloespf15pdp)

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