Daily Fade Maximum Strength SPF15: Package Insert and Label Information

DAILY FADE MAXIMUM STRENGTH SPF15- hydroquinone , avobenzone and octinoxate cream
Biocosmetic Research Labs

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.


Active Ingredients:

Hydroquinone 2%

Avobenzone 2%

Octinoxate 5%


Purpose:

Skin Lightener Cream


Uses:

For gradual fading of dark (brownish) spots. This product is not intended for use in the prevention of sunburn.


Warnings:

Avoid Contact with eyes. Children under 12 years of age; Do not use unless directed by a doctor.

Some users may experience a mild irritation. If skin irritation becomes severe, stop use and consult a doctor.


Directions:

Apply evenly in the morning or as directed by a doctor. Sun exposure should be limited; the product contains an effective sun protection factor in order to minimize the reoccurrence of skin darking.


Other Ingredients:

Water, Stearic Acid, Hydrogenated Vegetable Oil, Cetyl Alcohol, Coco-Caprylate/Caprate, DEA-Cetyl Phosphate, C12-15 Alkyl Benzoate, Propylene Glycol, Dimethicone, Sodium Palmitoyl Proline, Nymphaea Alba Flower Extract, Polyacrylamide, C13-14 Isoparaffin, Lureth-7, Tocopheryl Acetate, Sodium PCA, Citrus Unshiu Peel Extract, Cellulose Gum, Fragrance, EDTA, Sodium Sulfite, Sodium Methabisulfite, Glycerin, Triethanolamine, Phenoxyethanol, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben, Caramel.

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DAILY FADE MAXIMUM STRENGTH SPF15
hydroquinone spf15 cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-308
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone (Hydroquinone) Hydroquinone 2 g in 100 g
Avobenzone (Avobenzone) Avobenzone 2 g in 100 g
Octinoxate (Octinoxate) Octinoxate 5 g in 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59735-308-56 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 56.8 g in 1 TUBE This package is contained within the CARTON (59735-308-56)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part358 06/03/2009
Labeler — Biocosmetic Research Labs (078870292)

Revised: 06/2009 Biocosmetic Research Labs

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