FDA.reportPublic FDA data

PRIME PRIMER HYDRATING BALM

Manufacturer
F&CO Co., Ltd.
Effective date
2014-08-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:35:26

Label at a glance#

ProductPRIME PRIMER HYDRATING BALM
Active ingredientTitanium Dioxide
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient: Titanium Dioxide 0.1%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:
Cyclopentasiloxane, Methyl Trimenthicone, Neopentyl Glycol Diethylhexanoate, Methyl Methacrylate Crosspolymer, Dextrin Palmitate, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cyclohexasiloxane, Aluminum Starch Octenylsuccinate, Stearoyl Inulin, Microcrystalline Wax, Silica, Diisostearyl Malate, Butylparaben, Fragrance(Parfum), Water, Polyglyceryl-2 Triisostearate, Macadamia Integrifolia Seed Oil, Montmorillonite, Corylus Americana (Hazel) Seed Oil, Butylene Glycol, Blue 1 Lake (CI 42090), Yellow 5 Lake (CI 19140), Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Glyceryl Caprylate, Onsen-sui, Phenoxyethanol

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen

CAUTION

WARNINGS SECTION

CAUTION:
If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

How to Use

INDICATIONS & USAGE SECTION

How to Use: Smooth over bare skin, especially where pores and fine lines are visible, to mattify skin.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Dosage & Administration:
Oil-free, mineral-based hydrating & mattifying balm that can be used under makeup to smooth away the look of pores & fine lines and minimize shine for even makeup application.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
Aluminum Starch OctenylsuccinateINACTIVE INGREDIENTI9PJ0O62941
Neopentyl Glycol DiethylhexanoateINACTIVE INGREDIENTU68ZV6W62C1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69106-15069106-150-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Neopentyl Glycol DiethylhexanoateU68ZV6W62CIACT
Aluminum Starch OctenylsuccinateI9PJ0O6294IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 1 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Aluminum Starch OctenylsuccinateALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294CREAM / TOPICAL321 mgExact identifier — unii candidate

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
84efea03-9cfb-4795-9ca5-4280d9491130154e4f9e-fa35-4212-9ef4-a96b9d994df52014-08-18WarningsExact identifier
spl id: 84efea03-9cfb-4795-9ca5-4280d9491130
spl set id: 154e4f9e-fa35-4212-9ef4-a96b9d994df5

Reported adverse events (FAERS/openFDA)#

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