FDA.reportPublic FDA data

PRIME PRIMER BB

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 01:35:27

Label at a glance#

ProductPRIME PRIMER BB SHEER
Active ingredientTitanium Dioxide, Octinoxate, Zinc Oxide
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Titanium Dioxide 9.69%, Ethylhexyl Methoxycinnamate 5.0%, Zinc Oxide 2.94%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:
Water, Cyclopentasiloxane, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Dimethicone, PEG-10 Dimethicone, Triethylhexanoin, Methyl Methacrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Sodium Chloride, Iron Oxides (CI 77492), Sorbitan Sesquioleate, Aluminum Hydroxide, Glyceryl Behenate, Polyglyceryl-6 Octastearate, Iron Oxides (CI 77491), Stearic Acid, Methylparaben, Chlorophenesin, Fragrance(Parfum), Triethoxycaprylylsilane, Propylparaben, Iron Oxides (CI 77499), Disodium EDTA, Coral Powder, Silica, Butylene Glycol, Fomes Officinalis (Mushroom) Extract, Glycerin, Phenoxyethanol, Portulaca Oleracea Extract, PEG-40 Hydrogenated Castor Oil, Algin, Phenyl Trimethicone, Hydrogenated Lecithin, Glycine Soja (Soybean) Oil, Lecithin, Sodium Benzoate, Potassium Sorbate, Alcohol Denat., Polysorbate 60, rh-Oligopeptide-1

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: Moisturize your skin and use fingertips to apply a pearl-size amount evenly.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Dosage & Administration:
Prime Primer BB Cream visibly reduces discoloration and darkening with Sebum Control & Primer benefits that finishes lightweight and sleek.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

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
WaterINACTIVE INGREDIENT059QF0KO0R1

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
69106-18069106-180-01

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
Octinoxate4Y5P7MUD51ACTIB
Zinc OxideSOI2LOH54ZACTIM
Water059QF0KO0RIACT
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
c5529b40-6053-4e66-bb11-426358163845ff3366ef-5bdb-4b90-bcb1-36ab94d9f44e2014-08-18WarningsExact identifier
spl id: c5529b40-6053-4e66-bb11-426358163845
spl set id: ff3366ef-5bdb-4b90-bcb1-36ab94d9f44e

Reported adverse events (FAERS/openFDA)#

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