SPL v2
SPL
SPL Set ID 2272012f-777a-34d6-e063-6294a90a03cc
Routes
CUTANEOUS TOPICAL
Published
Effective Date 2024-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.4 g) Allantoin (3.2 g)
Inactive Ingredients
Mineral Oil Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-18

Description

TITANIUM DIOXIDE 8% ALLANTOIN 0.2%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

This foundation, with moisturizing,even complexion effect, contains color simulation technology. Moist, light, fast absorption,not dry. Glows and creates silky smooth skin for an even skin tone. Contains SPF 50

Dosage and Administration

HOW TO USE: Apply evenly to clean skin before sun exposure. Rub in a circular motion with your fingers until it matches your skin tone.

Description

TITANIUM DIOXIDE 8% ALLANTOIN 0.2%

Section 44425-7

Keep away from light and in a dry place.

Section 50565-1

Keep away from children. Do not swallow.

Section 50566-9

lf skin becomes red or irritated, discontinue use immediately and wash with water.

Section 50567-7

keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged skin.

Section 51727-6

AQUA

MINERAL OIL

GLYCERIN

CAPRYLIC/CAPRIC TRIGLYCERIDE

CETYL PEG/PPG-10/1 DIMETHICONE

DIMETHICONE

ALOE BARBADENSIS LEAF JUICE

MAGNESIUM SULFATE

TRIMETHYLSILOXYSILICATE

CYCLOPENTASILOXANE

PHENOXYETHANOL

CERA ALBA

BIFIDA FERMENT LYSATE

CI 77492

CI 77491

AVENA SATIVA (OAT) PEPTIDE

ALUMINA

BUTYLENE GLYCOL

1,2-HEXANEDIOL

SODIUM HYALURONATE

Section 51945-4

Section 53413-1

Contact name: Jessie Peng

Company phone number: +1 818 579 7288

Company e-mail: [email protected]

Section 55105-1

Sunscreen

Section 55106-9

TITANIUM DIOXIDE 8%

ALLANTOIN 0.2%


Structured Label Content

Indications and Usage (34067-9)

This foundation, with moisturizing,even complexion effect, contains color simulation technology. Moist, light, fast absorption,not dry. Glows and creates silky smooth skin for an even skin tone. Contains SPF 50

Dosage and Administration (34068-7)

HOW TO USE: Apply evenly to clean skin before sun exposure. Rub in a circular motion with your fingers until it matches your skin tone.

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

Keep away from light and in a dry place.

Section 50565-1 (50565-1)

Keep away from children. Do not swallow.

Section 50566-9 (50566-9)

lf skin becomes red or irritated, discontinue use immediately and wash with water.

Section 50567-7 (50567-7)

keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged skin.

Section 51727-6 (51727-6)

AQUA

MINERAL OIL

GLYCERIN

CAPRYLIC/CAPRIC TRIGLYCERIDE

CETYL PEG/PPG-10/1 DIMETHICONE

DIMETHICONE

ALOE BARBADENSIS LEAF JUICE

MAGNESIUM SULFATE

TRIMETHYLSILOXYSILICATE

CYCLOPENTASILOXANE

PHENOXYETHANOL

CERA ALBA

BIFIDA FERMENT LYSATE

CI 77492

CI 77491

AVENA SATIVA (OAT) PEPTIDE

ALUMINA

BUTYLENE GLYCOL

1,2-HEXANEDIOL

SODIUM HYALURONATE

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Contact name: Jessie Peng

Company phone number: +1 818 579 7288

Company e-mail: [email protected]

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

TITANIUM DIOXIDE 8%

ALLANTOIN 0.2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)