FDA.reportPublic FDA data

Principal Secret Reclaim Sunscreen For Face and Body SPF 30

Manufacturer
Guthy-Renker LLC
Effective date
2024-01-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:08

Label at a glance#

ProductPrincipal Secret Reclaim Sunscreen For Face and Body SPF 30
Active ingredientMeradimate, Octinoxate, Oxybenzone, Zinc Oxide
Label structure11 sections

Indications and uses

helps prevent sunburn

Dosage and administration

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.

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

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED 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.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

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 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL
SECRET®

RECLAIM®
with Argireline®

Sunscreen
For Face & Body
SPF 30

75 mL 2.5 FL. OZ.

PRINCIPAL DISPLAY PANEL - 75 mL Tube Label
PRINCIPAL DISPLAY PANEL - 75 mL Tube 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70605-014-212022-04-19C16284748780-1c7ccaba7-0e6a-fd44-e053-dadaa90aa01bPrincipal Secret ® Reclaim ® Sunscreen For Face & Body SPF 30
70605-014-212021-07-23C16284748780-1c7ccaba7-0e6a-fd44-e053-dadaa90aa01bPrincipal Secret ® Reclaim ® Sunscreen For Face & Body SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70605-014-21Principal Secret Reclaim Sunscreen For Face and Body SPF 3075 mL in 1 TUBECREAM753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70605-014PRINCIPAL SECRET RECLAIM SUNSCREEN FOR FACE AND BODY SPF 30 (MERADIMATE, OCTINOXATE, OXYBENZONE, AND ZINC OXIDE) CREAM [GUTHY-RENKER LLC]3Current NDC, Legacy NDC, 1 package rows20240113_4a183aa2-deda-4b26-a126-6f98cfbdb0f3.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70605-01470605-014-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
MeradimateJ9QGD60OUZACTIB
Octinoxate4Y5P7MUD51ACTIB
Oxybenzone95OOS7VE0YACTIB
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Ethylhexyl Ethylhexanoate430RJA6715IACT
Pentylene Glycol50C1307PZGIACT
TriisononanoinXF4K22WN6TIACT
Sodium Dihydroxycetyl PhosphateYWI33EV595IACT
Glyceryl Stearate SEFCZ5MH785IIACT
Cetostearyl Alcohol2DMT128M1SIACT
Yellow Wax2ZA36H0S2VIACT
Ahnfeltiopsis ConcinnaSMF2K46G8DIACT
Acetyl Hexapeptide-8L4EL31FWILIACT
Lecithin, Soybean1DI56QDM62IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
MUSKMELONZV095H5633IACT
BANANA4AJZ4765R9IACT
Ascorbyl PalmitateQN83US2B0NIACT
Pantothenic Acid19F5HK2737IACT
VITIS VINIFERA LEAFR1H893D80EIACT
IRIS X GERMANICA NOTHOVAR. FLORENTINA ROOTM30XO5X4XDIACT
ABELMOSCHUS MOSCHATUS SEEDUN2QZ55I88IACT
LEVOMENOL24WE03BX2TIACT
Hydrogenated Palm GlyceridesYCZ8EM144QIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
PhytonadioneA034SE7857IACT
Polyacrylamide (10000 MW)E2KR9C9V2IIACT
C13-14 IsoparaffinE4F12ROE70IACT
Laureth-7Z95S6G8201IACT
Xanthan GumTTV12P4NEEIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
Butylene Glycol3XUS85K0RAIACT
PhenoxyethanolHIE492ZZ3TIACT
MethylparabenA2I8C7HI9TIACT
ChlorphenesinI670DAL4SZIACT
Benzoic Acid8SKN0B0MIMIACT

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 Reclaim Sunscreen For Face and Body SPF 30MERADIMATE, OCTINOXATE, OXYBENZONE, AND ZINC OXIDEGuthy-Renker LLC4a183aa2-deda-4b26-a126-6f98cfbdb0f32024-01-10WarningsExact identifier
ndc (package): 70605-014-21
ndc (product): 70605-014
ndc11 (package): 70605001421
spl id: f61f0753-6794-4f18-8b4e-60ff19ec0334
spl set id: 4a183aa2-deda-4b26-a126-6f98cfbdb0f3

Reported adverse events (FAERS/openFDA)#

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