Sunscreen Cream

Sunscreen Cream
SPL v1
SPL
SPL Set ID 1d5866a3-b480-eab6-e063-6294a90accb1
Route
TOPICAL
Published
Effective Date 2024-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1.5 g) Homosalate (3 g) Octisalate (2.5 g) Octocrylene
Inactive Ingredients
C20-22 Alcohols Sodium Hydroxide Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s At 1.0%) Medium-chain Triglycerides Bemotrizinol Arginine Pentylene Glycol Hydroxyacetophenone Cocoa Butylene Glycol Iscotrizinol Aluminum Starch Octenylsuccinate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Caprylyl Glycol Tocopherol Stearyl Glycyrrhetinate Sorbitan Isostearate Butylated Hydroxytoluene Anhydrous Dextrose Potassium Sorbate Octinoxate Ensulizole Xanthan Gum Allantoin Fragrance 13576 Polysorbate 60 Edetate Disodium Water Cetostearyl Alcohol Dicaprylyl Carbonate Titanium Dioxide C20-22 Alkyl Phosphate Sodium Stearoyl Glutamate Phenoxyethanol Squalane Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-16

Description

Avobenzone 3%, Homosalate 6%,Octisalate 5%, Octocrylene 5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

Use when going out

Description

Avobenzone 3%, Homosalate 6%,Octisalate 5%, Octocrylene 5%

Section 50565-1

If product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.

Section 50566-9

rash occurs

Section 50567-7

keep out of eyes. Rinse with water to remone

Section 50570-1

on damaged or broken skin

Section 51727-6

Water, Ethylhexyl Methoxycinnamate, Butylene Glycol, Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid, Cetearyl Alcohol, Dicaprylyl Carbonate, Diethylhexyl Butamido Triazone, Titanium Dioxide, C20-22 Alkyl Phosphate, Aluminum Starch Octenylsuccinate, C20-22 Alcohols, Arginine, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Sodium Stearoyl Glutamate, Sodium Hydroxide, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Squalane, Silica, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Allantoin, Caprylyl Glycol, Tocopherol (Vitamin E), Stearyl Glycyrrhetinate, Polysorbate 60, Disodium EDTA, Fragrance, Sorbitan Isostearate, BHT, Caprylic/Capric Triglyceride, Theobroma Cacao (Cocoa) Seed Extract, Glucose, Potassium Sorbate

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 3%, Homosalate 6%,Octisalate 5%, Octocrylene 5%


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

Use when going out

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.

Section 50566-9 (50566-9)

rash occurs

Section 50567-7 (50567-7)

keep out of eyes. Rinse with water to remone

Section 50570-1 (50570-1)

on damaged or broken skin

Section 51727-6 (51727-6)

Water, Ethylhexyl Methoxycinnamate, Butylene Glycol, Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid, Cetearyl Alcohol, Dicaprylyl Carbonate, Diethylhexyl Butamido Triazone, Titanium Dioxide, C20-22 Alkyl Phosphate, Aluminum Starch Octenylsuccinate, C20-22 Alcohols, Arginine, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Sodium Stearoyl Glutamate, Sodium Hydroxide, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Squalane, Silica, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Allantoin, Caprylyl Glycol, Tocopherol (Vitamin E), Stearyl Glycyrrhetinate, Polysorbate 60, Disodium EDTA, Fragrance, Sorbitan Isostearate, BHT, Caprylic/Capric Triglyceride, Theobroma Cacao (Cocoa) Seed Extract, Glucose, Potassium Sorbate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 3%, Homosalate 6%,Octisalate 5%, Octocrylene 5%


Advanced Ingredient Data


Raw Label Data

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