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

Principal Secret Advanced with Hydrospheres Continuous Moisture SPF8 by

Drug Labeling and Warnings

Principal Secret Advanced with Hydrospheres Continuous Moisture SPF8 by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.5%
Octisalate 1.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• children under 6 months: Ask a doctor

Inactive ingredients

Water, Ethylhexyl Palmitate, Cetyl Lactate, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Cetyl Dimethicone, PEG-8/SMDI Copolymer, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Ascorbyl Palmitate, Avena Sativa (Oat) Kernel Extract, Vitis Vinifera (Grape) Seed Extract, Yeast Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Leuconostoc/Radish Root Ferment Filtrate, Tocopheryl Linoleate/Oleate, Retinyl Palmitate, Sodium Hyaluronate, Panthenol, Phosphatidylcholine, Phospholipids, Papain, C13-14 Isoparaffin, Ethylhexylglycerin, Lecithin, Carbomer, Polyacrylamide, Laureth-7, Sodium Hydroxide, Trisodium EDTA, Potassium Sorbate, Phenoxyethanol

Other information

• protect this product from excessive heat and direct sun.

Questions or comments?

Within US 1-800-510-4961

SPL UNCLASSIFIED SECTION

Dist. by: Guthy-Renker®
PO Box 14383 Palm Desert,
CA 92255-4383

PRINCIPAL DISPLAY PANEL - 57 g Jar Label

FRAGRANCE FREE
DERMATOLOGIST TESTED
CLINICALLY TESTED

Dist. by: Guthy-Renker®
PO Box 14383 Palm Desert,
CA 92255-4383
buyprincipalsecret.com
Made in the USA of Foreign and
Domestic Components
Principal Secret® is a trademark in the
United States and might be trademark
in other countries.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
Glycerin (UNII: PDC6A3C0OX)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PANTHENOL (UNII: WV9CM0O67Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WINE GRAPE (UNII: 3GOV20705G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PANTOTHENIC ACID (UNII: 19F5HK2737)
PHYTONADIONE (UNII: A034SE7857)
BERGAMOT OIL (UNII: 39W1PKE3JI)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)
PAPAIN (UNII: A236A06Y32)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LAURETH-7 (UNII: Z95S6G8201)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PEG-8 LAURATE (UNII: 762O8IWA10)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-017-34	57 g in 1 JAR; Type 0: Not a Combination Product	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/31/2017

Labeler - Guthy-Renker LLC (948861877)