Aqua Protection Sunscreen Broad Spectrum Spf50 Lotion
FDA Label NDC 14268-122

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Englewood Lab, Inc. for the product Aqua Protection Sunscreen Broad Spectrum Spf50 (NDC 14268-122). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone, 3.0%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene, 5.0%

Purpose

Sunscreen

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.

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

ir rash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally to all exposed skin 15 minutes before sun exposure.
  • Reapply at least evey 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating:
  • 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 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.

Othe Information

Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

WATER (AQUA), DIPROPYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, BUTYLOCTYL SALICYLATE, CETEARETH-20, ETHYLHEXYL METHOXYCRYLENE, ACRYLATES COPOLYMER, POLYSORBATE 60, SORBITAN STEARATE, CAPRYLYL GLYCOL, CETEARYL OLIVATE, PANTHENOL, SORBITAN OLIVATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, TROMETHAMINE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, 1,2-HEXANEDIOL, ISOHEXADECANE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, MUSA SAPIENTUM FLOWER EXTRACT, ROSA DAMASCENA FLOWER WATER, PYRUS COMMUNIS (PEAR) FRUIT EXTRACT, BHT, OCTYLDODECANOL, PRUNUS DOMESTICA FRUIT EXTRACT, POLYSORBATE 80, CUCUMIS MELO (MELON0 FRUIT EXTRACT, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, SORBITAN OLEATE, HEDERA HELIX (IVY) LEAF/STEM EXTRACT, XANTHAN GUM, BUTYLENE GLYCOL, GLUCOSYLRUTIN, EQUISETUM ARVENSE EXTRACT, LYCOPODIUM CLAVATUM EXTRACT, SODIUM HYALURONIC ACID, HYDROLYZED SODIUM HYALURONATE, HYDROXYPROPYLTRIMONIUM HYALURONATE, POTASSIUM HYALURONATE, SODIUM HYALURONATE CROSSPOLYMER, BETULA PLATYPHYLLA JAPONICA JUICE, PENTYLENE GLYCOL, SODIUM ACETYLATED HYALURONATE

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