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Package Insert and Label Information: Daily Fade SPF15

By Biocosetic Research Labs | Last revised: 6 March 2006

DAILY FADE SPF15- avobenzone and octinoxate cream
Biocosetic 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

Avobenzone 2%

Octinoxate 5%


Purpose

Sunscreen


Uses

For gradual fading of dark {brownish} spots.


Warnings

Keep out of eyes. Rinse with water to remove.

Do not use on children under 12 years of age.

Stop use and see a doctor if irritation occurs.


Directions

Apply evenly in the morning. Reapply as needed or after towel drying, swimming or sweating.


Other Ingredients

Water (Aqua), Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, BUtyrosermum Parkii (Shea Butter), Glyceryl Stearate, Undecylenoyl phenylalanine, Caprylic/Capric Triglyceride, Cetyl Alcohol, PEG-100 Stearate, Silica, Glycerin, Triethanolamine, Polyglyceryl-3 Laurate, Tocopheryl Acetate,Steareth-20, Tetrahexyldecyl Ascorbate, Ceteth-20, Mel {honey extract}, Diethylhexyl Syringylidenemalonate, Sodium Palmitoyl Proline, Nymphaea Alba Flower Extract,, Camellia Sinensis Leaf Extract, Citrus Unshiu Peel Extract, Butylene Glycol, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance (Parfum), Phenoxyethanol, Disodium EDTA, Chlorphenesin, Benzoic Acid, Sorbic Acid, Caramel.

Image of carton Fade Creme
(click image for full-size original)

DAILY FADE SPF15
sunscreen cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-306
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
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:59735-306-56 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 56 g in 1 TUBE This package is contained within the CARTON (59735-306-56)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/06/2006
Labeler — Biocosetic Research Labs (078870292)

Revised: 03/2006 Biocosetic Research Labs

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