SPL v1
SPL
SPL Set ID 3b80cb21-5b5a-6872-e063-6394a90a6d03
Route
CUTANEOUS
Published
Effective Date 2025-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (1 g) Zinc Oxide (6 g)
Inactive Ingredients
Ci 19140 Glyceryl Stearate C13-16 Isoparaffin Butylene Glycol Potassium Cetyl Phosphate Propylparaben Ceteareth-20 Aqua Methylparaben 3-o-ethyl Ascorbic Acid Cetearyl Alcohol Allantoin Edetate Disodium Mineral Oil Urea Trolamine Iodopropynyl Butylcarbamate Carbomer Dmdm Hydantoin Peg-100 Stearate Glycerin Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-04

Description

Apply generously and evenly over wholebody 20 minutes before sun exposure.Reapply frequently


Medication Information

Warnings and Precautions

1、For external use only, avoid contact with eyes when used

2、Keep out of reach of children

Indications and Usage

Very high, broad spectrum protection for the body against UVA and UVB. Suitable for all skin types, especially those with very clear, sensitive phototypes and sun intolerance.

Dosage and Administration

Apply generously and evenly over whole body 20 minutes before sun exposure. Reapply frequently.

Description

Apply generously and evenly over wholebody 20 minutes before sun exposure.Reapply frequently

Section 50565-1

KEEP OUT OF REACH OF CHILDREN SECTION

Section 51727-6

AQUA

MINERAL OIL

GLYCERIN

CETEARYL ALCOHOL

UREA

DIMETHICONE

GLYCERYL STEARATE

CETEARETH-20

POTASSIUM CETYL PHOSPHATE

PEG-100 STEARATE

TRIETHANOLAMINE

ALLANTOIN

CARBOMER

C13-16 ISOALKANE

DMDM HYDANTOIN

AROMA

METHYLPARABEN

PROPYLPARABEN

3-O-ETHYL ASCORBIC ACID

DISODIUM EDTA

BUTYLENE GLYCOL

IODOPROPYNYL BUTYLCARBAMATE

CI 19140

Section 51945-4

Active Ingredients

NIACINAMIDE1mg/

Zinc oxide6%

Uses:

Apply generously and evenly over wholebody 20 minutes before sun exposure.Reapply frequently.

The storage method:

Store sealed in a cool place and out of sunlight

AQUA

MINERAL OIL

GLYCERIN

CETEARYL ALCOHOL

UREA

DIMETHICONE

GLYCERYL STEARATE

CETEARETH-20

POTASSIUM CETYL PHOSPHATE

PEG-100 STEARATE

TRIETHANOLAMINE

ALLANTOIN

CARBOMER

C13-16 ISOALKANE

DMDM HYDANTOIN

AROMA

METHYLPARABEN

PROPYLPARABEN

3-O-ETHYL ASCORBIC ACID

DISODIUM EDTA

BUTYLENE GLYCOL

IODOPROPYNYL BUTYLCARBAMATE

CI 19140

Section 55105-1

Apply generously and evenly over wholebody 20 minutes before sun exposure.Reapply frequently

Section 55106-9

Active Ingredients

NIACINAMIDE1mg/

Zinc oxide6%


Structured Label Content

Indications and Usage (34067-9)

Very high, broad spectrum protection for the body against UVA and UVB. Suitable for all skin types, especially those with very clear, sensitive phototypes and sun intolerance.

Dosage and Administration (34068-7)

Apply generously and evenly over whole body 20 minutes before sun exposure. Reapply frequently.

Warnings and Precautions (34071-1)

1、For external use only, avoid contact with eyes when used

2、Keep out of reach of children

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN SECTION

Section 51727-6 (51727-6)

AQUA

MINERAL OIL

GLYCERIN

CETEARYL ALCOHOL

UREA

DIMETHICONE

GLYCERYL STEARATE

CETEARETH-20

POTASSIUM CETYL PHOSPHATE

PEG-100 STEARATE

TRIETHANOLAMINE

ALLANTOIN

CARBOMER

C13-16 ISOALKANE

DMDM HYDANTOIN

AROMA

METHYLPARABEN

PROPYLPARABEN

3-O-ETHYL ASCORBIC ACID

DISODIUM EDTA

BUTYLENE GLYCOL

IODOPROPYNYL BUTYLCARBAMATE

CI 19140

Section 51945-4 (51945-4)

Active Ingredients

NIACINAMIDE1mg/

Zinc oxide6%

Uses:

Apply generously and evenly over wholebody 20 minutes before sun exposure.Reapply frequently.

The storage method:

Store sealed in a cool place and out of sunlight

AQUA

MINERAL OIL

GLYCERIN

CETEARYL ALCOHOL

UREA

DIMETHICONE

GLYCERYL STEARATE

CETEARETH-20

POTASSIUM CETYL PHOSPHATE

PEG-100 STEARATE

TRIETHANOLAMINE

ALLANTOIN

CARBOMER

C13-16 ISOALKANE

DMDM HYDANTOIN

AROMA

METHYLPARABEN

PROPYLPARABEN

3-O-ETHYL ASCORBIC ACID

DISODIUM EDTA

BUTYLENE GLYCOL

IODOPROPYNYL BUTYLCARBAMATE

CI 19140

Section 55105-1 (55105-1)

Apply generously and evenly over wholebody 20 minutes before sun exposure.Reapply frequently

Section 55106-9 (55106-9)

Active Ingredients

NIACINAMIDE1mg/

Zinc oxide6%


Advanced Ingredient Data


Raw Label Data

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