SPL v1
SPL
SPL Set ID 45328c13-31ae-3bd2-e063-6394a90a814f
Route
TOPICAL
Published
Effective Date 2025-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Helianthus Annuus (sunflower) Seed Oil Unsaponifiables (0.0046 mg)
Inactive Ingredients
Mineral Oil Titanium Dioxide Ceresin Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Allantoin Isononyl Isononanoate Ceramide Np Ectoin 1,2-hexanediol Acetyl Hexapeptide-8

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-05

Description

MINERAL OIL、TITANIUM DIOXIDE、OZOKERITE、ISONONYL ISONONANOATE、CETYL PEG/PPG-10/1 DIMETHICONE、1,2-HEXANEDIOL、CERAMIDE NP、ACETYL HEXAPEPTIDE-8、ECTOIN、ALLANTOIN


Medication Information

Warnings and Precautions

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Indications and Usage

1. Clean your face and keep it dry.

2. Apply an appropriate amount of this product evenly on the face and body skin.

Dosage and Administration

1. Clean your face and keep it dry.

2. Apply an appropriate amount of this product evenly on the face and body skin.

Description

MINERAL OIL、TITANIUM DIOXIDE、OZOKERITE、ISONONYL ISONONANOATE、CETYL PEG/PPG-10/1 DIMETHICONE、1,2-HEXANEDIOL、CERAMIDE NP、ACETYL HEXAPEPTIDE-8、ECTOIN、ALLANTOIN

Section 44425-7

Store in a cool and dry place.

Section 50565-1

Please keep out of reach of children. Do not swallow.

Section 50566-9

Discontinue use if signs of irritation or rash occur.

Section 50567-7

1. Clean your face and keep it dry.

2. Apply an appropriate amount of this product evenly on the face and body skin.

Section 50570-1

Discontinue use if signs of irritation or rash occur.

Section 51727-6

MINERAL OIL、TITANIUM DIOXIDE、OZOKERITE、ISONONYL ISONONANOATE、CETYL PEG/PPG-10/1 DIMETHICONE、1,2-HEXANEDIOL、CERAMIDE NP、ACETYL HEXAPEPTIDE-8、ECTOIN、ALLANTOIN

Section 51945-4

Section 55105-1

1. Effectively resists UV rays and protects the skin from sun damage.

2. Helps maintain the youthful radiance and vitality of the skin for a long time.

3. Provides lasting moisturizing, leaving the skin hydrated and comfortable.

4. The texture is refreshing and non-greasy, and the semi-matte makeup effect is beautiful.

Section 55106-9

MINERAL OIL、TITANIUM DIOXIDE、OZOKERITE、ISONONYL ISONONANOATE、CETYL PEG/PPG-10/1 DIMETHICONE、1,2-HEXANEDIOL、CERAMIDE NP、ACETYL HEXAPEPTIDE-8、ECTOIN、ALLANTOIN


Structured Label Content

Indications and Usage (34067-9)

1. Clean your face and keep it dry.

2. Apply an appropriate amount of this product evenly on the face and body skin.

Dosage and Administration (34068-7)

1. Clean your face and keep it dry.

2. Apply an appropriate amount of this product evenly on the face and body skin.

Warnings and Precautions (34071-1)

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Section 44425-7 (44425-7)

Store in a cool and dry place.

Section 50565-1 (50565-1)

Please keep out of reach of children. Do not swallow.

Section 50566-9 (50566-9)

Discontinue use if signs of irritation or rash occur.

Section 50567-7 (50567-7)

1. Clean your face and keep it dry.

2. Apply an appropriate amount of this product evenly on the face and body skin.

Section 50570-1 (50570-1)

Discontinue use if signs of irritation or rash occur.

Section 51727-6 (51727-6)

MINERAL OIL、TITANIUM DIOXIDE、OZOKERITE、ISONONYL ISONONANOATE、CETYL PEG/PPG-10/1 DIMETHICONE、1,2-HEXANEDIOL、CERAMIDE NP、ACETYL HEXAPEPTIDE-8、ECTOIN、ALLANTOIN

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

1. Effectively resists UV rays and protects the skin from sun damage.

2. Helps maintain the youthful radiance and vitality of the skin for a long time.

3. Provides lasting moisturizing, leaving the skin hydrated and comfortable.

4. The texture is refreshing and non-greasy, and the semi-matte makeup effect is beautiful.

Section 55106-9 (55106-9)

MINERAL OIL、TITANIUM DIOXIDE、OZOKERITE、ISONONYL ISONONANOATE、CETYL PEG/PPG-10/1 DIMETHICONE、1,2-HEXANEDIOL、CERAMIDE NP、ACETYL HEXAPEPTIDE-8、ECTOIN、ALLANTOIN


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)