SPL v1
SPL
SPL Set ID 2be1dfce-1881-aab3-e063-6394a90ac464
Route
CUTANEOUS
Published
Effective Date 2025-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bis-ethylhexyloxyphenol Methoxyphenyl Triazine (0.772 g) Zinc Oxide (11.89646 g) Ethylhexyl Methoxycinnamate (5.83874 g) Titanium Dioxide (8.02712 g)
Inactive Ingredients
Magnesium Stearate Ci 77492 Ethylhexyl Palmitate Bht Sodium Sulfate Triethoxycaprylylsilane Ginger 1,2-hexanediol Aluminum Hydroxide Helianthus Annuus (sunflower) Seed Oil Sodium Chloride Talc Dimethicone Stearic Acid Purslane Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Limnanthes Alba (meadowfoam) Seed Oil Alpha-tocopherol Acetate Phenoxyethanol Crithmum Maritimum Hydroxyacetophenone Boron Nitride Polyhydroxystearic Acid (2300 Mw) Oenothera Biennis (evening Primrose) Oil Argania Spinosa Kernel Oil Ci 77491 Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Macadamia Ternifolia Seed Oil Glycyrrhizic Acid Aqua Ci 77499 Silica Mica Glycerin Ectoin Bisabolol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-01-17
Description

Active ingredients: ETHYLHEXYL METHOXYCINNAMATE(5.83874g/100g), BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE(0.772g/100g), ZINC OXIDE(11.89646/100g), TITANIUM DIOXIDE(8.02712g/100g)

Medication Information

Warnings and Precautions

Warnings:

1.IF YOU HAVE SENSITIVE SKIN, PLEASE TRY IT LOCALLY FIRST ANDUSE IT AFTER NO DISCOMFORT;

2.DISCONTINUE USE IMMEDIATELY IF YOU FEELUNWELL AFTER USE;

3.KEEP OUT OF REACH OF YOUNG CHILDREN TO AVOID ACCI.DENTAL INGESTION, NOT BE USED FOR CHILDREN UNDER 3 YEARS OF AGE.

Indications and Usage

Indications & usage section:SUNSCREEN PRESSED POWDER,SETTING MAKEUP WHILE PROTECTING AGAINST UVA/UVB

Dosage and Administration

DIRECTIONS:

SIMPLY DAB AN APPROPRIATE AMOUNT OF POWDER WITH THE PUFF AND APPLY TO THE FACE FROM THE INSIDE OUT BY PATTING AND PRESSING EVENLY.

Description

Active ingredients: ETHYLHEXYL METHOXYCINNAMATE(5.83874g/100g), BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE(0.772g/100g), ZINC OXIDE(11.89646/100g), TITANIUM DIOXIDE(8.02712g/100g)

Section 50565-1

KEEP OUT OF REACH OF YOUNG CHILDREN TO AVOID ACCIDENTAL INGESTION,NOT BE USED FOR CHILDREN UNDER 3YEARS OF AGE.

Section 51727-6

Inactive ingredients:

TALC, MICA, SILICA, METHYL METHACRYLATE CROSSPOLYMER, BORON NITRIDE, MAGNESIUM STEARATE, TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYL PALMITATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DIMETHICONE, PHENOXYETHANOL, ALUMINUM HYDROXIDE, STEARIC ACID, CI 77492, PORTULACA OLERACEA EXTRACT, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, POLYHYDROXYSTEARIC ACID, CI 77491, PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE, GLYCYRRHIZIC ACID, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, MACADAMIA TERNIFOLIA SEED OIL, ECTOIN, AQUA, CI 77499, BISABOLOL, GLYCERIN, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, CRITHMUM MARITIMUM EXTRACT, BHT, SODIUM CHLORIDE, SODIUM SULFATE, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE

Section 51945-4

See label

Section 55105-1

Use to Absorbs UVA and UVB rays to protect skin from UV rays.Prevent sunburn, tanning, and skin photoaging

Section 55106-9

Active ingredients: ETHYLHEXYL METHOXYCINNAMATE(5.83874g/100g), BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE(0.772g/100g), ZINC OXIDE(11.89646/100g), TITANIUM DIOXIDE(8.02712g/100g)

Section 60561-8

PLEASE KEEP IN A DRY PLACE AT ROOM TEMPERATURE AND AVOID DIR-ECT SUNLIGHT.

Structured Label Content

Indications and Usage (34067-9)

Indications & usage section:SUNSCREEN PRESSED POWDER,SETTING MAKEUP WHILE PROTECTING AGAINST UVA/UVB

Dosage and Administration (34068-7)

DIRECTIONS:

SIMPLY DAB AN APPROPRIATE AMOUNT OF POWDER WITH THE PUFF AND APPLY TO THE FACE FROM THE INSIDE OUT BY PATTING AND PRESSING EVENLY.

Warnings and Precautions (34071-1)

Warnings:

1.IF YOU HAVE SENSITIVE SKIN, PLEASE TRY IT LOCALLY FIRST ANDUSE IT AFTER NO DISCOMFORT;

2.DISCONTINUE USE IMMEDIATELY IF YOU FEELUNWELL AFTER USE;

3.KEEP OUT OF REACH OF YOUNG CHILDREN TO AVOID ACCI.DENTAL INGESTION, NOT BE USED FOR CHILDREN UNDER 3 YEARS OF AGE.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF YOUNG CHILDREN TO AVOID ACCIDENTAL INGESTION,NOT BE USED FOR CHILDREN UNDER 3YEARS OF AGE.

Section 51727-6 (51727-6)

Inactive ingredients:

TALC, MICA, SILICA, METHYL METHACRYLATE CROSSPOLYMER, BORON NITRIDE, MAGNESIUM STEARATE, TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYL PALMITATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DIMETHICONE, PHENOXYETHANOL, ALUMINUM HYDROXIDE, STEARIC ACID, CI 77492, PORTULACA OLERACEA EXTRACT, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, POLYHYDROXYSTEARIC ACID, CI 77491, PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE, GLYCYRRHIZIC ACID, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, MACADAMIA TERNIFOLIA SEED OIL, ECTOIN, AQUA, CI 77499, BISABOLOL, GLYCERIN, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, CRITHMUM MARITIMUM EXTRACT, BHT, SODIUM CHLORIDE, SODIUM SULFATE, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE

Section 51945-4 (51945-4)

See label

Section 55105-1 (55105-1)

Use to Absorbs UVA and UVB rays to protect skin from UV rays.Prevent sunburn, tanning, and skin photoaging

Section 55106-9 (55106-9)

Active ingredients: ETHYLHEXYL METHOXYCINNAMATE(5.83874g/100g), BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE(0.772g/100g), ZINC OXIDE(11.89646/100g), TITANIUM DIOXIDE(8.02712g/100g)

Section 60561-8 (60561-8)

PLEASE KEEP IN A DRY PLACE AT ROOM TEMPERATURE AND AVOID DIR-ECT SUNLIGHT.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:23.060962 · Updated: 2026-03-14T23:07:05.651363