FDA.reportPublic FDA data

REMAN HOMME SUN PROTECTION

Manufacturer
Pf Nature
Effective date
2014-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:23

Label at a glance#

ProductREMAN HOMME SUN PROTECTION
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Titanium Dioxide 9.7%, Zinc Oxide 7.55%, Ethylhexyl Methoxycinnamate 7%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:
Cetyl Ethylhexanoate, Mica, Hexyl Laurate, Phenyl Trimethicone, Dimethicone, Methyl Methacrylate Crosspolymer, Nylon-12, Synthetic Wax, Ceresin, Ricinus Communis (Castor) Seed Oil, Sorbitan Olivate, Cetyl Palmitate, Ethylene/Propylene Copolymer, Sorbitan Sesquioleate,
Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Sorbitan Palmitate, Sorbitan Stearate, sucrose distearate, Stearalkonium Hectorite, Caprylyl Glycol, Ethylhexylglycerin, Fragrance, Propylene Carbonate, Tocopheryl Acetate, Tropolone, BHT, CI 77492, Argania Spinosa Kernel Oil, Zizania Aquatica Extract, CI 77491, Amber Powder, Amethyst Powder, Nephrite Powder, Pearl Powder, Tourmaline, Ruby Powder, Phenoxyethanol

PURPOSE

OTC - PURPOSE SECTION

Purpose: UVA/UVB Protection

WARNINGS

WARNINGS SECTION

Warnings:
1. When the use of this cosmetic product causes the following side effects, you should stop using it. If you continue to use it, those side effects can worsen. So, you should consult a dermatologist about them.
a. Side effects such as red spots, swelling, pruritus and stimulation can occur when using this product.
b. The above side effects can occur on the applied part due to direct sunlight.
2. Please do not put this cosmetic product on wounded or damaged skin due to eczema and dermatitis.
3. When it gets into your eyes, please wash it off immediately with clean water.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children:
Please keep this product out of the reach of babies and children.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indication and usage:
Please close the cap after use. Once it is unpacked, please use them up immediately as it dries up quickly.
Please do not keep this product in places with very high or low temperatures.
And please keep it out of direct sunlight.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage and administration:
After using basic goods, apply the product to forehead and nose in T shape, and cheeks in U shape. Then spread evenly with fingers and pat.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809382390882GTIN-13: 8809382390882
EAN-13: 8809382390882
GTIN storage (14 digits): 08809382390882		reman homme sun protection carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69226-010-012019-11-27C16284748780-19855e2a2-33a8-60a7-e053-dbdaa90a05bd7bea7d8a-b868-4163-ac04-459159e71e9e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69226-010-01REMAN HOMME SUN PROTECTION22 g in 1 CARTONSTICK221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69226-010REMAN HOMME SUN PROTECTION (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE) STICK [PF NATURE]1Legacy NDC, 1 package rows20140930_7bea7d8a-b868-4163-ac04-459159e71e9e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC CATIONACTIVE MOIETY13S1S8SF371
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
MicaINACTIVE INGREDIENTV8A1AW08801

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69226-01069226-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
OCTINOXATE4Y5P7MUD51ACTIB
MicaV8A1AW0880IACT
Dimethicone92RU3N3Y1OIACT

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
a02d6e27-8c77-4410-9777-1f6571a8a9967bea7d8a-b868-4163-ac04-459159e71e9e2014-09-30WarningsExact identifier
spl id: a02d6e27-8c77-4410-9777-1f6571a8a996
spl set id: 7bea7d8a-b868-4163-ac04-459159e71e9e

Reported adverse events (FAERS/openFDA)#

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