ADVANCED CONTINUOUSMOISTURE® SPF 8

Principal Secret by

Drug Labeling and Warnings

Principal Secret by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL SECRET  ADVANCED WITH HYDROSPHERES CONTINUOUS MOISTURE SPF8- octinoxate and octisalate cream 
THE PROACTIV COMPANY LLC

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.

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ADVANCED CONTINUOUS
MOISTURE® SPF 8

To Use

Apply with a gentle upward motion to face and neck.

WARNING

For external use only.

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

OTC - STOP USE SECTION

If irritation develops, discontinue use.

OTC - DO NOT USE SECTION

Do not use on infants under 6 months old.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children.

Active Ingredients

Octinoxate (7.5%), Octisalate (1.0%)

Other Ingredients

Water (Eau), Ethylhexyl Palmitate, Cetyl Lactate, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Cetyl Dimethicone, Yeast Extract (Extrait de levure), Retinyl Palmitate, Tocopheryl Linoleate, Panthenol, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Phospholipids, Tocopheryl Acetate, Ascorbyl Palmitate, Pantothenic Acid, Phytonadione, Citrus Aurantium Dulcis (Orange) Oil, Limonene, Magnesium Ascorbyl Phosphate, Avena Sativa (Oat) Kernel Extract, Papain, Lecithin, Polyacrylamide, Laureth-7, C13-14 Isoparaffin, PEG-8/SMDI Copolymer, Triethanolamine, Carbomer, Trisodium EDTA, Phenoxyethanol, Methylparaben, Propylparaben

SPL UNCLASSIFIED SECTION

Distributed by Guthy-Renker
Palm Desert, CA 92260,
Guthy Renker® (UK) Ltd.,
London UK WC2E 8AA,
Sydney Australia 2138,
Auckland New Zealand,
Toronto Ontario Canada M1B 3W2

PRINCIPAL DISPLAY PANEL - 57g Label

ADVANCED
WITH
HYDROSPHERES ®

Continuous Moisture ® SPF 8

PRINCIPAL SECRET   ADVANCED WITH HYDROSPHERES CONTINUOUS MOISTURE SPF8
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-541
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 mg  in 0.1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	1 mg  in 0.1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-541-34	57 g in 1 JAR; Type 0: Not a Combination Product	05/10/2002	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/10/2002	01/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020

Document Id: b4c8b264-6159-4d28-a377-0f07af057733

34390-5

Set id: 1f923d90-3617-462c-bc4d-61a4d2f479b2

Version: 2

Effective Time: 20200129