PRINCIPAL SECRET RECLAIM OIL CONTROL HYDRATOR SPF-8- titanium dioxide cream

Principal Secret Reclaim Oil Control hydrator SPF-8 by

Drug Labeling and Warnings

Principal Secret Reclaim Oil Control hydrator SPF-8 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 Fact Label

Active ingredient

Titanium Dioxide 4.0%

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.

• Stop use and ask a doctor if rash occurs.

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

• 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.
• Use a water-resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Children under 6 months: Ask a doctor.

Other Information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Dimethicone, Tapioca Starch Polymethylsilsesquioxane, Butylene Glycol, Methyl Glucose Sesquistearate, PEG-20 Methyl Glucose Sesquistearate, Polysorbate 20, Squalane, Polyacrylate-13, Sorbitan Isostearate, Di-PPG-3 Myristyl Ether Adipate, Acetyl Hexapeptide-8, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Glucosamine HCl, Pisum Sativum (Pea) Extract, Bambusa Vulgaris Leaf/Stem Extract, Laminaria Saccharina Extract, Ahnfeltia Concinna Extract, Camellia Oleifera Leaf Extract, Camellia Sinensis Leaf Extract, Vitis Vinifera (Grape) Seed Extract, Cucumis Melo (Melon) Fruit Extract, Glycosaminoglycans, Hydrolyzed Prunus Domestica, Zinc PCA, Glycerin, Xanthan Gum, Polyisobutene, Sodium Myristol Sarcosinate, Tetrasodium EDTA, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Phenoxyethanol

Questions or comments?

Within US 1-800-510-4961

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Distributed by Guthy-Renker® Palm Desert, CA 92260 USA

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

PRINCIPAL
SECRET®

RECLAIM®
with Argireline®

Oil Control Hydrator
SPF 8

Oil-Free Moisturizer

1.7 FL. Oz. / 50 ml

INGREDIENTS AND APPEARANCE

PRINCIPAL SECRET RECLAIM OIL CONTROL HYDRATOR SPF-8 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	4 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol (UNII: 3XUS85K0RA)
Methyl Glucose Sesquistearate (UNII: V1YW10H14D)
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)
Polysorbate 20 (UNII: 7T1F30V5YH)
Squalane (UNII: GW89575KF9)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Di-PPG-3 Myristyl Ether Adipate (UNII: T32481VTXW)
Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
PEA (UNII: W4X7H8GYFM)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
AHNFELTIOPSIS CONCINNA (UNII: SMF2K46G8D)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
MUSKMELON (UNII: ZV095H5633)
ZINC PIDOLATE (UNII: C32PQ86DH4)
Glycerin (UNII: PDC6A3C0OX)
Xanthan Gum (UNII: TTV12P4NEE)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D)
EDETATE SODIUM (UNII: MP1J8420LU)
Ethylhexylglycerin (UNII: 147D247K3P)
Hexylene Glycol (UNII: KEH0A3F75J)
Caprylyl Glycol (UNII: 00YIU5438U)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-028-95	50 mL in 1 BOTTLE; 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 final	part352	12/31/2017

Labeler - Guthy-Renker LLC (948861877)