FDA.reportPublic FDA data

Principal Secret Advanced with Hydrospheres Continuous Moisture SPF8

Manufacturer
Guthy-Renker LLC | Universal Packaging Systems, Inc. (DBA Paklab)
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:06:56

Label at a glance#

ProductPrincipal Secret Advanced with Hydrospheres Continuous Moisture SPF8
Active ingredientOctinoxate, Octisalate
Label structure11 sections

Indications and uses

helps prevent sunburn

Dosage and administration

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

Storage and handling

protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%
Octisalate 1.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

PRINCIPAL DISPLAY PANEL - 57 g Jar Label
PRINCIPAL DISPLAY PANEL - 57 g Jar Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70605-017-342024-01-08C16284748780-1c7ccaba7-244e-fd44-e053-dadaa90aa01bPrincipal Secret ® Advanced with Hydrospheres Continuous Moisture SPF8
70605-017-342023-07-28C16284748780-1c7ccaba7-244e-fd44-e053-dadaa90aa01bPrincipal Secret ® Advanced with Hydrospheres Continuous Moisture SPF8
70605-017-342022-01-30C16284748780-1c7ccaba7-244e-fd44-e053-dadaa90aa01bPrincipal Secret ® Advanced with Hydrospheres Continuous Moisture SPF8
70605-017-342021-07-23C16284748780-1c7ccaba7-244e-fd44-e053-dadaa90aa01bPrincipal Secret ® Advanced with Hydrospheres Continuous Moisture SPF8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70605-017-34Principal Secret Advanced with Hydrospheres Continuous Moisture SPF857 g in 1 JARCREAM575

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70605-017PRINCIPAL SECRET ADVANCED WITH HYDROSPHERES CONTINUOUS MOISTURE SPF8 (OCTINOXATE AND OCTISALATE) CREAM [GUTHY-RENKER LLC]5Current NDC, Legacy NDC, 1 package rows20240110_f4310455-8b3f-40a9-8674-fe7fc3abaced.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70605-01770605-017-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Octisalate4X49Y0596WACTIB
ETHYLHEXYL PALMITATE2865993309IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
GlycerinPDC6A3C0OXIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
PANTHENOLWV9CM0O67ZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
WINE GRAPE3GOV20705GIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
ASCORBYL PALMITATEQN83US2B0NIACT
PANTOTHENIC ACID19F5HK2737IACT
PHYTONADIONEA034SE7857IACT
BERGAMOT OIL39W1PKE3JIIACT
LIMONENE, (+)-GFD7C86Q1WIACT
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FIACT
PAPAINA236A06Y32IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
LAURETH-7Z95S6G8201IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
PEG-8 LAURATE762O8IWA10IACT
TROLAMINE9O3K93S3TKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Principal Secret Advanced with Hydrospheres Continuous Moisture SPF8OCTINOXATE AND OCTISALATEGuthy-Renker LLCf4310455-8b3f-40a9-8674-fe7fc3abaced2024-01-08WarningsExact identifier
ndc (package): 70605-017-34
ndc (product): 70605-017
ndc11 (package): 70605001734
spl id: be5ac4d5-c1b3-4ce5-9afd-be6b0716d8f2
spl set id: f4310455-8b3f-40a9-8674-fe7fc3abaced

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.