SPL v1
SPL
SPL Set ID 3e6fe9f3-486b-bba7-e063-6294a90adf37
Route
TOPICAL
Published
Effective Date 2025-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4 g) Ethylhexyl Methoxycinnamate (7.5 g)
Inactive Ingredients
Caprylyl Methicone Polymethylsilsesquioxane (4.5 Microns) Methylene Bis-benzotriazolyl Tetramethylbutylphenol Lonicera Japonica Flower Ginger C12-15 Alkyl Benzoate Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Aqua Polyhydroxystearic Acid (2300 Mw) Cyclohexasiloxane Decyl Glucoside Diethylamino Hydroxybenzoyl Hexyl Benzoate Malva Sylvestris Whole Hydrolyzed Glycosaminoglycans (bovine; 50000 Mw) Dipropylene Glycol Saccharomyces Lysate Viola Philippica Whole Taraxacum Officinale (dandelion) Root Polyacrylate Crosspolymer-6 Dimethicone Sorbitan Oleate Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Sodium Hyaluronate Xanthan Gum Chamomile Bht Cyclopentasiloxane Sodium Acetylated Hyaluronate Ethylhexylglycerin Potassium Hydroxide Bisabolol Chlorphenesin Isohexadecane Hyaluronic Acid Aloe Barbadensis Leaf Juice Potassium Cetyl Phosphate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Paeonia Lactiflora Root Polyglyceryl-10 Myristate Cetearyl Alcohol C20-22 Alkyl Phosphate Hydroxyacetophenone Glycerin Edetate Disodium Polysorbate 80 Propylene Glycol 1,2-hexanediol Silica Bis-ethylhexyloxyphenol Methoxyphenyl Triazine Phenoxyethanol Alpha-tocopherol Acetate C20-22 Alcohols

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-10

Description

WATER SACCHAROMYCES FERMENT FILTRATE DIPROPYLENE GLYCOL GLYCERIN C12-15 ALKYL BENZOATE CAPRYLYL METHICONE CYCLOPENTASILOXANE POLYMETHYLSILSESQUIOXANE METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL(NANO) BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE CYCLOHEXASILOXANE C20-22 ALKYL PHOSPHATE POTASSIUM CETYL PHOSPHATE HYDROXYACETOPHENONE SILICA C20-22 ALCOHOLS POLYGLYCERYL-10 MYRISTATE CETEARYL ALCOHOL POLYHYDROXYSTEARIC ACID TOCOPHERYL ACETATE CHLORPHENESIN DECYL GLUCOSIDE POLYACRYLATE CROSSPOLYMER-6 ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER POTASSIUM HYDROXIDE DISODIUM EDTA BISABOLOL DIMETHICONE ISOHEXADECANE POLYSORBATE 80 PROPYLENE GLYCOL SODIUM HYALURONATE CROSSPOLYMER SODIUM HYALURONATE SORBITAN OLEATE XANTHAN GUM PHENOXYETHANOL VIOLA YEDOENSIS EXTRACT PAEONIA LACTIFLORA ROOT EXTRACT TARAXACUM OFFICINALE (DANDELION) RHIZOME/ROOT EXTRACT CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT BHT 1,2-HEXANEDIOL LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT MALVA SYLVESTRIS (MALLOW) FLOWER EXTRACT HYDROLYZED SODIUM HYALURONATE SODIUM ACETYLATED HYALURONATE HYALURONIC ACID HYDROLYZED GLYCOSAMINOGLYCANS ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT ETHYLHEXYLGLYCERIN HYDROXYPROPYLTRIMONIUM HYALURONATE ALOE BARBADENSIS LEAF JUICE


Medication Information

Warnings and Precautions



PRECAUTIONS:

Do not use for food purposes.Do not use on broken skin; avoid contact with eyes.

If product gets into eyes, rinse immediately with plenty of water. Discontinue use if discomfort occurs.

Indications and Usage



FUNCTION:

Blocks UV rays. protects against sun damage, moisturizes and nourishes,

feels light and breathable, and nourishes and beautifies the skin.

Dosage and Administration



USAGE:For daytime use, apply an appropriate amount evenly to the face and body.

Description

WATER SACCHAROMYCES FERMENT FILTRATE DIPROPYLENE GLYCOL GLYCERIN C12-15 ALKYL BENZOATE CAPRYLYL METHICONE CYCLOPENTASILOXANE POLYMETHYLSILSESQUIOXANE METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL(NANO) BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE CYCLOHEXASILOXANE C20-22 ALKYL PHOSPHATE POTASSIUM CETYL PHOSPHATE HYDROXYACETOPHENONE SILICA C20-22 ALCOHOLS POLYGLYCERYL-10 MYRISTATE CETEARYL ALCOHOL POLYHYDROXYSTEARIC ACID TOCOPHERYL ACETATE CHLORPHENESIN DECYL GLUCOSIDE POLYACRYLATE CROSSPOLYMER-6 ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER POTASSIUM HYDROXIDE DISODIUM EDTA BISABOLOL DIMETHICONE ISOHEXADECANE POLYSORBATE 80 PROPYLENE GLYCOL SODIUM HYALURONATE CROSSPOLYMER SODIUM HYALURONATE SORBITAN OLEATE XANTHAN GUM PHENOXYETHANOL VIOLA YEDOENSIS EXTRACT PAEONIA LACTIFLORA ROOT EXTRACT TARAXACUM OFFICINALE (DANDELION) RHIZOME/ROOT EXTRACT CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT BHT 1,2-HEXANEDIOL LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT MALVA SYLVESTRIS (MALLOW) FLOWER EXTRACT HYDROLYZED SODIUM HYALURONATE SODIUM ACETYLATED HYALURONATE HYALURONIC ACID HYDROLYZED GLYCOSAMINOGLYCANS ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT ETHYLHEXYLGLYCERIN HYDROXYPROPYLTRIMONIUM HYALURONATE ALOE BARBADENSIS LEAF JUICE

Section 50565-1

Keep out of eyes: In case of contact with eyes, please fush thoroughly with water.

Section 51727-6

WATER

SACCHAROMYCES FERMENT FILTRATE

DIPROPYLENE GLYCOL

GLYCERIN

C12-15 ALKYL BENZOATE

CAPRYLYL METHICONE

CYCLOPENTASILOXANE

POLYMETHYLSILSESQUIOXANE

METHYLENE BIS-BENZOTRIAZOLYL

TETRAMETHYLBUTYLPHENOL(NANO)

BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL

TRIAZINE

DIETHYLAMINO HYDROXYBENZOYL HEXYL

BENZOATE

CYCLOHEXASILOXANE

C20-22 ALKYL PHOSPHATE

POTASSIUM CETYL PHOSPHATE

HYDROXYACETOPHENONE

SILICA

C20-22 ALCOHOLS

POLYGLYCERYL-10 MYRISTATE

CETEARYL ALCOHOL

POLYHYDROXYSTEARIC ACID

TOCOPHERYL ACETATE

CHLORPHENESIN

DECYL GLUCOSIDE

POLYACRYLATE CROSSPOLYMER-6

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

SODIUM ACRYLATE/SODIUM

ACRYLOYLDIMETHYL TAURATE COPOLYMER

POTASSIUM HYDROXIDE

DISODIUM EDTA

BISABOLOL

DIMETHICONE

ISOHEXADECANE

POLYSORBATE 80

PROPYLENE GLYCOL

SODIUM HYALURONATE CROSSPOLYMER

SODIUM HYALURONATE

SORBITAN OLEATE

XANTHAN GUM

PHENOXYETHANOL

VIOLA YEDOENSIS EXTRACT

PAEONIA LACTIFLORA ROOT EXTRACT

TARAXACUM OFFICINALE (DANDELION)

RHIZOME/ROOT EXTRACT

CHAMOMILLA RECUTITA (MATRICARIA)

FLOWER EXTRACT

BHT

1,2-HEXANEDIOL

LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT

MALVA SYLVESTRIS (MALLOW) FLOWER

EXTRACT

HYDROLYZED SODIUM HYALURONATE

SODIUM ACETYLATED HYALURONATE

HYALURONIC ACID

HYDROLYZED GLYCOSAMINOGLYCANS

ZINGIBER OFFICINALE (GINGER) ROOT

EXTRACT

ETHYLHEXYLGLYCERIN

HYDROXYPROPYLTRIMONIUM HYALURONATE

ALOE BARBADENSIS LEAF JUICE

Section 51945-4

Section 55105-1

Sun Protection

Section 55106-9

ETHYLHEXYL METHOXYCINNAMATE 7.5%

TITANIUM DIOXIDE(NANO) 4%


Structured Label Content

Indications and Usage (34067-9)



FUNCTION:

Blocks UV rays. protects against sun damage, moisturizes and nourishes,

feels light and breathable, and nourishes and beautifies the skin.

Dosage and Administration (34068-7)



USAGE:For daytime use, apply an appropriate amount evenly to the face and body.

Warnings and Precautions (34071-1)



PRECAUTIONS:

Do not use for food purposes.Do not use on broken skin; avoid contact with eyes.

If product gets into eyes, rinse immediately with plenty of water. Discontinue use if discomfort occurs.

Section 50565-1 (50565-1)

Keep out of eyes: In case of contact with eyes, please fush thoroughly with water.

Section 51727-6 (51727-6)

WATER

SACCHAROMYCES FERMENT FILTRATE

DIPROPYLENE GLYCOL

GLYCERIN

C12-15 ALKYL BENZOATE

CAPRYLYL METHICONE

CYCLOPENTASILOXANE

POLYMETHYLSILSESQUIOXANE

METHYLENE BIS-BENZOTRIAZOLYL

TETRAMETHYLBUTYLPHENOL(NANO)

BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL

TRIAZINE

DIETHYLAMINO HYDROXYBENZOYL HEXYL

BENZOATE

CYCLOHEXASILOXANE

C20-22 ALKYL PHOSPHATE

POTASSIUM CETYL PHOSPHATE

HYDROXYACETOPHENONE

SILICA

C20-22 ALCOHOLS

POLYGLYCERYL-10 MYRISTATE

CETEARYL ALCOHOL

POLYHYDROXYSTEARIC ACID

TOCOPHERYL ACETATE

CHLORPHENESIN

DECYL GLUCOSIDE

POLYACRYLATE CROSSPOLYMER-6

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

SODIUM ACRYLATE/SODIUM

ACRYLOYLDIMETHYL TAURATE COPOLYMER

POTASSIUM HYDROXIDE

DISODIUM EDTA

BISABOLOL

DIMETHICONE

ISOHEXADECANE

POLYSORBATE 80

PROPYLENE GLYCOL

SODIUM HYALURONATE CROSSPOLYMER

SODIUM HYALURONATE

SORBITAN OLEATE

XANTHAN GUM

PHENOXYETHANOL

VIOLA YEDOENSIS EXTRACT

PAEONIA LACTIFLORA ROOT EXTRACT

TARAXACUM OFFICINALE (DANDELION)

RHIZOME/ROOT EXTRACT

CHAMOMILLA RECUTITA (MATRICARIA)

FLOWER EXTRACT

BHT

1,2-HEXANEDIOL

LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT

MALVA SYLVESTRIS (MALLOW) FLOWER

EXTRACT

HYDROLYZED SODIUM HYALURONATE

SODIUM ACETYLATED HYALURONATE

HYALURONIC ACID

HYDROLYZED GLYCOSAMINOGLYCANS

ZINGIBER OFFICINALE (GINGER) ROOT

EXTRACT

ETHYLHEXYLGLYCERIN

HYDROXYPROPYLTRIMONIUM HYALURONATE

ALOE BARBADENSIS LEAF JUICE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sun Protection

Section 55106-9 (55106-9)

ETHYLHEXYL METHOXYCINNAMATE 7.5%

TITANIUM DIOXIDE(NANO) 4%


Advanced Ingredient Data


Raw Label Data

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