SPL v3
SPL
SPL Set ID 3264543c-e8f5-da9a-e063-6394a90ac8c6
Route
TOPICAL
Published
Effective Date 2025-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Methylene Bis-benzotriazolyl Tetramethylbutylphenol (2.5 mg) Octocrylene (2 mg) Ethylhexyl Methoxycinnamate (5 mg) Ethylhexyl Salicylate (3 mg)
Inactive Ingredients
Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Phenyl Trimethicone Propylene Glycol Caprylhydroxamic Acid C14-18 Mono-and Di-glycerides Pentylene Glycol Xanthan Gum Water Butylene Glycol Isohexadecane C12-15 Alkyl Benzoate Cetearyl Alcohol Glyceryl Stearate 1,2-hexanediol Diethylamino Hydroxybenzoyl Hexyl Benzoate Polysilicone-15 Polyglyceryl-3 Methylglucose Distearate Decyl Glucoside Glycerin Potassium Cetyl Phosphate Ethylhexyl Triazone Ethylhexylglycerin Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Edetate Disodium Sodium Hyaluronate Propylene Glycol Laurate Hydrogenated Polydecene (1500 Cst) Propanediol Arginine Tribehenin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-10

Description

Ethylhexyl Methoxycinnamate 5% Ethylhexyl Salicylate 3% Methylene Bis-benzotriazolyl tetramethylbutyiphenol 2.5% Octocrylene 2%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Ahigh-performance sunscreen providing broad-spectrum UVA/UVBprotection while hydrating and soothing the skin.

This lightweight,non-greasy formula is infused with advanced UV filters, Vitamin E. andaloe vera to protect against sun damage and nourish the skin.

Dosage and Administration

Reapplyevery 2 hours when exposed to sunlight.

Description

Ethylhexyl Methoxycinnamate 5% Ethylhexyl Salicylate 3% Methylene Bis-benzotriazolyl tetramethylbutyiphenol 2.5% Octocrylene 2%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use to broken orirritated skin

Section 50570-1

Avoid contact with eyes; rinse thoroughlyif contact occurs.

Section 51727-6

Water, Glycerin, Butylene Glycol, lsohexadecane, C12-15 AlkylBenzoate, Propylene Glycol Laurate, PhenylTrimethicone,Polysilicone-15,Diethylamino Hydroxybenzoyl Hexyl Benzoate.Hydrogenated Polydecene, Polyglyceryl-3 MethylglucoseDistearate,Potassium Cetyl phosphate, Cetearyl Alcohol.EthylhexylTriazone, Lauric/Myristic/Palmitic/Stearic GlyceridesPentylene Glycol,Tribehenin,Glyceryl Stearate,1.2-Hexanediol.Decyl Glucoside, Propanediol, Acrylates/C10-30 Alkyl AcrylateCrosspolymer, Arginine, Disodium Edta, PentaerythritylTetra-Di-f-Butyl Hydroxyhydrocinnamate, Sodium HyaluronateCaprylhydroxamic Acid, Propylene Glycol, Ethylhexylglycerin,Xanthan Gum

Section 51945-4

Section 53413-1

www.myabsolutskin.com

Section 55105-1

Sunscreen

Section 55106-9

Ethylhexyl Methoxycinnamate 5%

Ethylhexyl Salicylate 3%

Methylene Bis-benzotriazolyl tetramethylbutyiphenol 2.5%

Octocrylene 2%

Section 60561-8

Protect this product from excessive heat and direct sun. Limiting sunexposure , wearing protective clothing and using sunscreens mayreduce the risk of skin aging, skin cancer and other harmful effects ofthe sun.


Structured Label Content

Indications and Usage (34067-9)

Ahigh-performance sunscreen providing broad-spectrum UVA/UVBprotection while hydrating and soothing the skin.

This lightweight,non-greasy formula is infused with advanced UV filters, Vitamin E. andaloe vera to protect against sun damage and nourish the skin.

Dosage and Administration (34068-7)

Reapplyevery 2 hours when exposed to sunlight.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use to broken orirritated skin

Section 50570-1 (50570-1)

Avoid contact with eyes; rinse thoroughlyif contact occurs.

Section 51727-6 (51727-6)

Water, Glycerin, Butylene Glycol, lsohexadecane, C12-15 AlkylBenzoate, Propylene Glycol Laurate, PhenylTrimethicone,Polysilicone-15,Diethylamino Hydroxybenzoyl Hexyl Benzoate.Hydrogenated Polydecene, Polyglyceryl-3 MethylglucoseDistearate,Potassium Cetyl phosphate, Cetearyl Alcohol.EthylhexylTriazone, Lauric/Myristic/Palmitic/Stearic GlyceridesPentylene Glycol,Tribehenin,Glyceryl Stearate,1.2-Hexanediol.Decyl Glucoside, Propanediol, Acrylates/C10-30 Alkyl AcrylateCrosspolymer, Arginine, Disodium Edta, PentaerythritylTetra-Di-f-Butyl Hydroxyhydrocinnamate, Sodium HyaluronateCaprylhydroxamic Acid, Propylene Glycol, Ethylhexylglycerin,Xanthan Gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

www.myabsolutskin.com

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Ethylhexyl Methoxycinnamate 5%

Ethylhexyl Salicylate 3%

Methylene Bis-benzotriazolyl tetramethylbutyiphenol 2.5%

Octocrylene 2%

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun. Limiting sunexposure , wearing protective clothing and using sunscreens mayreduce the risk of skin aging, skin cancer and other harmful effects ofthe sun.


Advanced Ingredient Data


Raw Label Data

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