Tinted Cream Foundation

Manufacturer: LIBINVEST
Effective date: 2010-06-18
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:24:54

Label at a glance#

ProductBIO BEAUTY BIO DEFENSE TINTED FOUNDATION SPF 18

Active ingredientOCTINOXATE, TITANIUM DIOXIDE

Label structure8 sections

Indications and uses

Use as a foundation, helps prevent sunburn, higher SPF gives more sunburn protection.

Dosage and administration

Use in place of your normal foundation.

Contacts and useful links#

PhoneLabel contact714-560 0111

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENTS
OCTINOXATE 7.5%	Sunscreen
TITANIUM DIOXIDE 8.0%	Sunscreen

USES

INDICATIONS & USAGE SECTION

Use as a foundation, helps prevent sunburn, higher SPF gives more sunburn protection.

WARNINGS

WARNINGS SECTION

For external use only. Not to be swallowed. Avoid contact with the eyes.

OTC - STOP USE SECTION

Stop use and ask doctor if rash develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Use in place of your normal foundation.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, GLYCERYL STEARATE/ISOPROPYLENE GLYCOL STEARATE/GLYCERYLISOSTEARATE/OLETH-25/CETETH-25, ISODECETH-6, OLETH-10, ALUMINUM STEARATE, ALUMINA, SIMETHICONE, PROPYLENE GLYCOL DIPELARGONATE, METHYL METHACRYLATE CROSSPOLYMER, OCTYLDODECYL MYRISTATE, PALMITOYL PROLINE and MAGNESIUM PALMITOYL GLUTAMATE and SODIUM PALMITOYL SARCOSINATE, IRON OXIDES, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOLDIMETHYL TAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, BENZOPHENONE-3, GLYCERYL STEARATE and BEHENYL LAURYL MYRISTYL CETYL ALCOHOL and PALMITIC STEARIC ACID and LECITHIN, MAGNESIUM ALUMINUM SILICATE, BUTYROSPERMUM PARKII (SHEA BUTTER), CETYL ALCOHOL, PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, ISOBUTYLPARABEN, FRAGRANCE, TOCOPHERYL ACETATE, GUM XANTHAN, ALLANTION, METHYLISOTHIAZOLINONE.

SPL UNCLASSIFIED SECTION

Distributed by Primo Derma, Inc. Santa Ana, CA 92705
Tel: ++001-714-560 0111

PRINCIPAL DISPLAY PANEL - 50 ml Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tinted
Cream Foundation

Sun Protectant
SPF 18

PRINCIPAL DISPLAY PANEL - 150 ml Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tinted
Cream Foundation

Sun Protectant
SPF 18

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52424-0001-0	2019-10-21	C162847	48780-1	956f9ecf-c4c2-621f-e053-dbdaa90a74ad	Tinted Cream Foundation
52424-0002-0	2019-10-21	C162847	48780-1	956f9ecf-c4c2-621f-e053-dbdaa90a74ad	Tinted Cream Foundation

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52424-0001-0	BIO BEAUTY BIO DEFENSE TINTED FOUNDATION SPF 18	50 mL in 1 BOTTLE, PLASTIC	CREAM	50	1
52424-0001-0	BIO BEAUTY BIO DEFENSE TINTED FOUNDATION SPF 18	1 in 1 BOX	CREAM	1	1
52424-0002-0	BIO BEAUTY BIO DEFENSE TINTED FOUNDATION SPF 18	150 mL in 1 BOTTLE, PLASTIC	CREAM	150	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52424-0001	BIO BEAUTY BIO DEFENSE (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [LIBINVEST]	1	Legacy NDC, 2 package rows	20100623_d9c6e3af-2d74-4cf9-af80-95ed9a5ea5cb.zip
52424-0002	BIO BEAUTY BIO DEFENSE (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [LIBINVEST]	1	Legacy NDC, 1 package rows	20100623_d9c6e3af-2d74-4cf9-af80-95ed9a5ea5cb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	1

Products#

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

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

BIO BEAUTY BIO DEFENSE TINTED FOUNDATION SPF 18
OCTINOXATE and TITANIUM DIOXIDE
OCTINOXATE
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52424-0001	52424-0001-0
52424-0002	52424-0002-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f94a641a-9896-4353-ac91-6c01e65a4baf			d9c6e3af-2d74-4cf9-af80-95ed9a5ea5cb	2010-06-18	Warnings	Exact identifier spl id: f94a641a-9896-4353-ac91-6c01e65a4baf spl set id: d9c6e3af-2d74-4cf9-af80-95ed9a5ea5cb

Reported adverse events (FAERS/openFDA)#

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