SPL v2
SPL
SPL Set ID 3dfe5db3-6a5b-24cd-e063-6394a90aa744
Route
TOPICAL
Published
Effective Date 2025-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Methylene Bis-benzotriazolyl Tetramethylbutylphenol (30 mg) Bis-ethylhexyloxyphenol Methoxyphenyl Triazine Ethylhexyl Triazone Butyloctyl Salicylate Diethylamino Hydroxybenzoyl Hexyl Benzoate
Inactive Ingredients
Caprylyl Methicone Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Tromethamine Polyglyceryl-3 Methylglucose Distearate Bambusa Arundinacea Stem Dibutyl Adipate Diisopropyl Sebacate Ammonium Acryloyldimethyltaurate/vp Copolymer Water Ethylhexylglycerin Propanediol 1,2-hexanediol Sorbitan Isostearate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Polyacrylate Crosspolymer-6 Behenyl Alcohol Niacinamide Tocopherol Sodium Stearoyl Glutamate Decyl Glucoside Potassium Cetyl Phosphate Butylene Glycol T-butyl Alcohol Glyceryl Caprylate Coco-caprylate/caprate Polymethylsilsesquioxane (4.5 Microns) Allantoin Adenosine Xanthan Gum Aloe Barbadensis Leaf Panthenol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-09-04

Description

Sunscreen Helps prevent sunburn Broad Spectrum UVA/UVB protection


Medication Information

Warnings and Precautions

For external use only.

Do not use on damaged or broken skin.

Stop use and consult a doctor if rash or irritation occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Avoid direct contact with eyes. In case of contact, rinse thoroughly with water.

Indications and Usage

Helps protect skin against harmful effects of UVA and UVB rays.

Can be used daily on the body to reduce risk of sun damage, premature aging, and skin dryness caused by sun exposure.

For external use only.

Dosage and Administration

Apply generously and evenly on body 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating.

For daily use, apply as the last step of skincare, before sun exposure.

Description

Sunscreen Helps prevent sunburn Broad Spectrum UVA/UVB protection

Section 50565-1

keep out of reach of children

Section 51727-6

Water

Dibutyl Adipate

Propanediol

Coco-Caprylate/Caprate

Niacinamide

Diisopropyl Sebacate

Polymethylsilsesquioxane

Poly C10-30 Alkyl Acrylate

Polyglyceryl-3 Methylglucose Distearate

Caprylyl Methicone

Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer

1,2-Hexanediol

Panthenol

Behenyl Alcohol

Glyceryl Caprylate

Sodium Stearoyl Glutamate

Potassium Cetyl Phosphate

Decyl Glucoside

Tromethamine

Ammonium Acryloyldimethyltaurate/VP Copolymer

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Polyacrylate Crosspolymer-6

Ethylhexylglycerin

Allantoin

Adenosine

Xanthan Gum

Sorbitan Isostearate

Tocopherol (Vitamin E)

Propylene Glycol

Butylene Glycol

t-Butyl Alcohol

Aloe Barbadensis Leaf Extract

Aphanothece Sacrum Polysaccharides

Bambusa Arundinacea Stem Extract

Section 51945-4

Content of labeling

Section 55105-1

Sunscreen

Helps prevent sunburn

Broad Spectrum UVA/UVB protection

Section 55106-9

Ethylhexyl Triazone

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine

Diethylamino Hydroxybenzoyl Hexyl Benzoate

Butyloctyl Salicylate

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol


Structured Label Content

Indications and Usage (34067-9)

Helps protect skin against harmful effects of UVA and UVB rays.

Can be used daily on the body to reduce risk of sun damage, premature aging, and skin dryness caused by sun exposure.

For external use only.

Dosage and Administration (34068-7)

Apply generously and evenly on body 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating.

For daily use, apply as the last step of skincare, before sun exposure.

Warnings and Precautions (34071-1)

For external use only.

Do not use on damaged or broken skin.

Stop use and consult a doctor if rash or irritation occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Avoid direct contact with eyes. In case of contact, rinse thoroughly with water.

Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

Water

Dibutyl Adipate

Propanediol

Coco-Caprylate/Caprate

Niacinamide

Diisopropyl Sebacate

Polymethylsilsesquioxane

Poly C10-30 Alkyl Acrylate

Polyglyceryl-3 Methylglucose Distearate

Caprylyl Methicone

Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer

1,2-Hexanediol

Panthenol

Behenyl Alcohol

Glyceryl Caprylate

Sodium Stearoyl Glutamate

Potassium Cetyl Phosphate

Decyl Glucoside

Tromethamine

Ammonium Acryloyldimethyltaurate/VP Copolymer

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Polyacrylate Crosspolymer-6

Ethylhexylglycerin

Allantoin

Adenosine

Xanthan Gum

Sorbitan Isostearate

Tocopherol (Vitamin E)

Propylene Glycol

Butylene Glycol

t-Butyl Alcohol

Aloe Barbadensis Leaf Extract

Aphanothece Sacrum Polysaccharides

Bambusa Arundinacea Stem Extract

Section 51945-4 (51945-4)

Content of labeling

Section 55105-1 (55105-1)

Sunscreen

Helps prevent sunburn

Broad Spectrum UVA/UVB protection

Section 55106-9 (55106-9)

Ethylhexyl Triazone

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine

Diethylamino Hydroxybenzoyl Hexyl Benzoate

Butyloctyl Salicylate

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol


Advanced Ingredient Data


Raw Label Data

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