FDA.reportPublic FDA data

Principal Secret Reclaim Oil Control hydrator SPF-8

Manufacturer
Guthy-Renker LLC
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:06:54

Label at a glance#

ProductPrincipal Secret Reclaim Oil Control hydrator SPF-8
Active ingredientTitanium Dioxide
Label structure11 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

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.

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Fact Label

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

  • 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.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs.

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

Other Information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Within US 1-800-510-4961

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL
SECRET®

RECLAIM®
with Argireline®

Oil Control Hydrator
SPF 8

Oil-Free Moisturizer

1.7 FL. Oz. / 50 ml

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70605-028-952024-01-08C16284748780-1c7ccaba7-0e6d-fd44-e053-dadaa90aa01bPrincipal Secret ® Reclaim ® Oil Control hydrator SPF-8
70605-028-952021-07-23C16284748780-1c7ccaba7-0e6d-fd44-e053-dadaa90aa01bPrincipal Secret ® Reclaim ® Oil Control hydrator SPF-8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70605-028-95Principal Secret Reclaim Oil Control hydrator SPF-850 mL in 1 BOTTLECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70605-028PRINCIPAL SECRET RECLAIM OIL CONTROL HYDRATOR SPF-8 (TITANIUM DIOXIDE) CREAM [GUTHY-RENKER LLC]3Current NDC, Legacy NDC, 1 package rows20240110_97b7cd4e-78aa-418b-a112-263971fa9827.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70605-02870605-028-95

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Water059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
Dimethicone92RU3N3Y1OIACT
Butylene Glycol3XUS85K0RAIACT
Methyl Glucose SesquistearateV1YW10H14DIACT
PEG-20 METHYL GLUCOSE SESQUISTEARATE0345752X7UIACT
Polysorbate 207T1F30V5YHIACT
SqualaneGW89575KF9IACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
Sorbitan Isostearate01S2G2C1E4IACT
Di-PPG-3 Myristyl Ether AdipateT32481VTXWIACT
Acetyl Hexapeptide-8L4EL31FWILIACT
HYALURONATE SODIUMYSE9PPT4THIACT
Tetrahexyldecyl Ascorbate9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
PEAW4X7H8GYFMIACT
BAMBUSA VULGARIS TOPFIW80T6P6VIACT
SACCHARINA LATISSIMA68CMP2MB55IACT
AHNFELTIOPSIS CONCINNASMF2K46G8DIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
VITIS VINIFERA SEEDC34U15ICXAIACT
MUSKMELONZV095H5633IACT
ZINC PIDOLATEC32PQ86DH4IACT
GlycerinPDC6A3C0OXIACT
Xanthan GumTTV12P4NEEIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
SODIUM MYRISTOYL SARCOSINATEJ07237209DIACT
EDETATE SODIUMMP1J8420LUIACT
Ethylhexylglycerin147D247K3PIACT
Hexylene GlycolKEH0A3F75JIACT
Caprylyl Glycol00YIU5438UIACT
Potassium Sorbate1VPU26JZZ4IACT
PhenoxyethanolHIE492ZZ3TIACT

Source Document#

Source XML · Source PDF

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 Reclaim Oil Control hydrator SPF-8TITANIUM DIOXIDEGuthy-Renker LLC97b7cd4e-78aa-418b-a112-263971fa98272024-01-08WarningsExact identifier
ndc (package): 70605-028-95
ndc (product): 70605-028
ndc11 (package): 70605002895
spl id: 37b6796f-1be8-4628-913a-f5a10228c877
spl set id: 97b7cd4e-78aa-418b-a112-263971fa9827

Reported adverse events (FAERS/openFDA)#

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