PRINCIPAL SECRET RECLAIM SUNSCREEN FOR FACE AND BODY SPF 30- meradimate, octinoxate, oxybenzone, and zinc oxide cream

Principal Secret Reclaim Sunscreen For Face and Body SPF 30 by

Drug Labeling and Warnings

Principal Secret Reclaim Sunscreen For Face and Body SPF 30 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

Octinoxate 7.5%
Meradimate 3.5%
Zinc Oxide 2.0%
Oxybenzone 2.0%

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 sub exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months Ask a doctor.

Inactive ingredients

Water, Ethylhexyl Ethylhexanoate, Pentylene Glycol, Triisononanoin, Sodium Dihydroxycetyl Phosphate, Glyceryl Stearate SE, Cetearyl Alcohol, Beeswax, Glycosaminoglycans, Ahnfeltiopsis Concinna Extract, Acetyl Hexapeptide-8, Phospholipids, Tocopheryl Acetate, Retinyl Palmitate, Cucumis Melo (Melon) Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Ascorbyl Palmitate, Pantothenic Acid, Vitis Vinifera (Grape) Leaf Extract, Iris Florentina Root Extract, Hibiscus Abelmoschus Extract, Bisabolol, Hydrogenated Palm Glycerides, Ceteareth-20, Polyglyceryl-3 Caprate, Phytonadione, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Xanthan Gum, Caprylic/Capric Triglyceride, Butylene Glycol, Phenoxyethanol, Methylparaben, Chlorphenesin, Benzoic Acid

Other Information

• protect this product from excessive heat and direct sun

Questions or comments?

800-510-4961

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 75 mL Tube Label

PRINCIPAL
SECRET®

RECLAIM®
with Argireline®

Sunscreen
For Face & Body
SPF 30

75 mL 2.5 FL. OZ.

INGREDIENTS AND APPEARANCE

PRINCIPAL SECRET RECLAIM SUNSCREEN FOR FACE AND BODY SPF 30 
meradimate, octinoxate, oxybenzone, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Meradimate (UNII: J9QGD60OUZ) (Meradimate - UNII:J9QGD60OUZ)	Meradimate	3.5 mg  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 mg  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	2 mg  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ethylhexyl Ethylhexanoate (UNII: 430RJA6715)
Pentylene Glycol (UNII: 50C1307PZG)
Triisononanoin (UNII: XF4K22WN6T)
Sodium Dihydroxycetyl Phosphate (UNII: YWI33EV595)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Yellow Wax (UNII: 2ZA36H0S2V)
Ahnfeltiopsis Concinna (UNII: SMF2K46G8D)
Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)
Lecithin, Soybean (UNII: 1DI56QDM62)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
MUSKMELON (UNII: ZV095H5633)
BANANA (UNII: 4AJZ4765R9)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Pantothenic Acid (UNII: 19F5HK2737)
VITIS VINIFERA LEAF (UNII: R1H893D80E)
IRIS X GERMANICA NOTHOVAR. FLORENTINA ROOT (UNII: M30XO5X4XD)
ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)
LEVOMENOL (UNII: 24WE03BX2T)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
Phytonadione (UNII: A034SE7857)
Polyacrylamide (10000 MW) (UNII: E2KR9C9V2I)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Laureth-7 (UNII: Z95S6G8201)
Xanthan Gum (UNII: TTV12P4NEE)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Butylene Glycol (UNII: 3XUS85K0RA)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylparaben (UNII: A2I8C7HI9T)
Chlorphenesin (UNII: I670DAL4SZ)
Benzoic Acid (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-014-21	75 mL in 1 TUBE; Type 0: Not a Combination Product	11/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	11/30/2017

Labeler - Guthy-Renker LLC (948861877)