Simple
FDA Label NDC 12488-2000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alberto-culver Usa Inc for the product Simple (NDC 12488-2000). 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 other, otc - purpose, use, warnings, otc - keep out of reach of children, otc - when using, otc - stop use, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Use

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Otc - When Using

→ Otc - Stop Use

→ Other Information

→ Directions

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 50g Jar Carton

Other

Drug Facts

Distributed by: Alberto Culver USA, Inc.
Melrose Park, IL 60160

Otc - Purpose

Active Ingredients:	Purpose:
Homosalate 12.0%	Sunscreen
Octisalate 5.0%	Sunscreen
Avobenzone 3.0%	Sunscreen
Octocrylene 2.7%	Sunscreen

Use

helps prevent sunburn.

Warnings

-For external use only.

Otc - Keep Out Of Reach Of Children

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

Otc - When Using

-When using this product keep out of eyes.
Rinse with water to remove.

Otc - Stop Use

-Stop use and ask a doctor if a rash and irritation develops and lasts.

Other Information

Intended for moderate daily sun protection from incidental sun exposure. For prolonged sun exposure, use additional sunscreen.

Directions

After cleansing, apply evenly to face and neck with fingertips prior to sun exposure. For children under 6 months of age, ask doctor.

Inactive Ingredients

Water (Aqua, Eau), Glycerin, C12-15 Alkyl Benzoate, Silica, Pentylene Glycol, Tocopheryl Acetate, Panthenol, Cetearyl Alcohol, Steareth-21, Steareth-2, Arachidyl Alcohol, Polyacrylamide, Caprylyl Glycol, Behenyl Alcohol, C13-14 Isoparaffin, Disodium EDTA, Xanthan Gum, Cetearyl Glucoside, Arachidyl Glucoside, Allantoin, Bisabolol, Laureth-7, Triethanolamine, Methylisothiazolinone, Phenoxyethanol.