PRINCIPAL SECRET ® RECLAIM RADIANCE®

Principal Secret Reclaim Radiance by

Drug Labeling and Warnings

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

Drug Details [pdf]

PRINCIPAL SECRET RECLAIM RADIANCE  FOUNDATION SPF15 MEDIUM- octinoxate and oxybenzone 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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PRINCIPAL
SECRET ®
RECLAIM
RADIANCE®

DIRECTIONS

Shake well. Smooth over the face with fingertips. Avoid direct contact with eyes. Reapply as needed.

WARNINGS

For external use only.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash or irritation develops and lasts.

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

ACTIVE INGREDIENTS

Ocinoxate 7.5%
Oxybenzone 3%

SPL UNCLASSIFIED SECTION

Dist. by Guthy-Renker"
Palm Desert, CA 92260

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

PRINCIPAL
SECRET ®

RECLAIM
RADIANCE®

Foundation
SPF 15

R®

1 FL. Oz. / 30 mL e

PRINCIPAL SECRET RECLAIM RADIANCE   FOUNDATION SPF15 MEDIUM
octinoxate and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-106
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 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CETETH-20 (UNII: I835H2IHHX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MYRISTYL LACTATE (UNII: 1D822OC34X)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
MYRISTYL LAURATE (UNII: 58U0NZN2BT)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-106-10	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/10/2009	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/10/2009	01/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2019

Document Id: 39a8a4ac-4477-4656-91f9-965276c72c53

34390-5

Set id: cef2eb30-a358-41f5-aaec-d27263e16147

Version: 2

Effective Time: 20190101