SPL v3
SPL
SPL Set ID 26db53cd-dd82-8790-e063-6394a90a92b1
Route
TOPICAL
Published
Effective Date 2025-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9.5 g) Octocrylene (5 g) Avobenzone (2.7 g) Octisalate (4.5 g)
Inactive Ingredients
Dimethicone Diisopropyl Sebacate Diethylhexyl Carbonate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-01

Description

Active ingredient(s) Homosalate 9.50% Octocrylene 5.00% Ethylhexyl Salicylate 4.50% Butyl Methoxydibenzoylmethane 2.70%


Medication Information

Warnings and Precautions

Warnings

■ For external use only.

Indications and Usage

Use(s)

■ 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

Directions

For sunscreen use:

■ Apply liberally 15 minutes before sun exposure

■ Use a water-resistant sunscreen if swimming or sweating

■ Reapply at least every 2 hours

Description

Other Information

■ Protect the product in this container from excessive heat and direct sun

Questions?

■ Please send an email to the following address

[email protected]

Section 51727-6

Inactive ingredients

Dimethicone, Methyl Methacrylate Crosspolymer, Synthetic Wax, Diethylhexyl Carbonate, Diisopropyl Sebacate, Diphenylsiloxy Phenyl Trimethicone, Isopropyl Palmitate, Polymethyl Methacrylate, Caprylyl Trimethicone, Diisostearyl Malate, Phenethyl Benzoate, Acrylates Copolymer, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Butyloctyl Salicylate, Polyethylene, Dimethicone/Vinyl Dimethicone Crosspolymer, Microcrystalline Wax, Polymethylsilsesquioxane, Ethylene/Propylene Copolymer, Curcuma Longa (Turmeric) Root Extract, Silica Dimethyl Silylate, Dimethicone Crosspolymer, Fragrance(Parfum), Camellia Japonica Seed Oil, Melia Azadirachta Flower Extract, Melia Azadirachta Leaf Extract, Corallina Officinalis Extract, Melia Azadirachta Bark Extract, Moringa Oleifera Seed Oil, Ocimum Sanctum Leaf Extract, Water, Butylene Glycol, Hydrolyzed Hyaluronic Acid, Ectoin, Ubiquinone, Hydrogenated Polyisobutene, Glycerin, 1,2-Hexanediol, Collagen Amino Acids, Propanediol, Haematococcus Pluvialis Extract, Sorbitan Laurate, Collagen, Aloe Barbadensis Leaf Extract, Dioscorea Japonica Root Extract, Hydroxyethylcellulose, Laminaria Japonica Extract, Sodium Hyaluronate, Ulmus Davidiana Root Extract, Viola Mandshurica Flower Extract, Acetyl Dipeptide-1 Cetyl Ester, Heptasodium Hexacarboxymethyl Dipeptide-12, Hydroxypropyltrimonium Hyaluronate, Acetyl Hexapeptide-8, Anemarrhena Asphodeloides Root Extract, Ascorbic Acid Polypeptide, Dextran, Hexapeptide-9, Sodium Acetylated Hyaluronate, Tripeptide-1, Tocopherol, Hyaluronic Acid, Collagen Extract, Hydrolyzed Sodium Hyaluronate, Sodium Hyaluronate Crosspolymer, Potassium Hyaluronate, Acetyl Octapeptide-3, Acetyl Tetrapeptide-2, Acetyl Tetrapeptide-3, Acetyl Tetrapeptide-5, Acetyl Tetrapeptide-9, Carnosine, Copper Tripeptide-1, Nonapeptide-1, Palmitoyl Pentapeptide-4, Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-5

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredient(s)

Homosalate 9.50%

Octocrylene 5.00%

Ethylhexyl Salicylate 4.50%

Butyl Methoxydibenzoylmethane 2.70%

72220 002 02: Mdp Peptide 9 Bio Sun Stick Pro (version 1)

72220 002 04: Mdp Peptide 9 Bio Sun Stick Pro (version 2)


Structured Label Content

Indications and Usage (34067-9)

Use(s)

■ 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)

Directions

For sunscreen use:

■ Apply liberally 15 minutes before sun exposure

■ Use a water-resistant sunscreen if swimming or sweating

■ Reapply at least every 2 hours

Warnings and Precautions (34071-1)

Warnings

■ For external use only.

Description (34089-3)

Other Information

■ Protect the product in this container from excessive heat and direct sun

Questions?

■ Please send an email to the following address

[email protected]

Section 51727-6 (51727-6)

Inactive ingredients

Dimethicone, Methyl Methacrylate Crosspolymer, Synthetic Wax, Diethylhexyl Carbonate, Diisopropyl Sebacate, Diphenylsiloxy Phenyl Trimethicone, Isopropyl Palmitate, Polymethyl Methacrylate, Caprylyl Trimethicone, Diisostearyl Malate, Phenethyl Benzoate, Acrylates Copolymer, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Butyloctyl Salicylate, Polyethylene, Dimethicone/Vinyl Dimethicone Crosspolymer, Microcrystalline Wax, Polymethylsilsesquioxane, Ethylene/Propylene Copolymer, Curcuma Longa (Turmeric) Root Extract, Silica Dimethyl Silylate, Dimethicone Crosspolymer, Fragrance(Parfum), Camellia Japonica Seed Oil, Melia Azadirachta Flower Extract, Melia Azadirachta Leaf Extract, Corallina Officinalis Extract, Melia Azadirachta Bark Extract, Moringa Oleifera Seed Oil, Ocimum Sanctum Leaf Extract, Water, Butylene Glycol, Hydrolyzed Hyaluronic Acid, Ectoin, Ubiquinone, Hydrogenated Polyisobutene, Glycerin, 1,2-Hexanediol, Collagen Amino Acids, Propanediol, Haematococcus Pluvialis Extract, Sorbitan Laurate, Collagen, Aloe Barbadensis Leaf Extract, Dioscorea Japonica Root Extract, Hydroxyethylcellulose, Laminaria Japonica Extract, Sodium Hyaluronate, Ulmus Davidiana Root Extract, Viola Mandshurica Flower Extract, Acetyl Dipeptide-1 Cetyl Ester, Heptasodium Hexacarboxymethyl Dipeptide-12, Hydroxypropyltrimonium Hyaluronate, Acetyl Hexapeptide-8, Anemarrhena Asphodeloides Root Extract, Ascorbic Acid Polypeptide, Dextran, Hexapeptide-9, Sodium Acetylated Hyaluronate, Tripeptide-1, Tocopherol, Hyaluronic Acid, Collagen Extract, Hydrolyzed Sodium Hyaluronate, Sodium Hyaluronate Crosspolymer, Potassium Hyaluronate, Acetyl Octapeptide-3, Acetyl Tetrapeptide-2, Acetyl Tetrapeptide-3, Acetyl Tetrapeptide-5, Acetyl Tetrapeptide-9, Carnosine, Copper Tripeptide-1, Nonapeptide-1, Palmitoyl Pentapeptide-4, Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-5

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredient(s)

Homosalate 9.50%

Octocrylene 5.00%

Ethylhexyl Salicylate 4.50%

Butyl Methoxydibenzoylmethane 2.70%

72220 002 02: Mdp Peptide 9 Bio Sun Stick Pro (version 1) (72220-002-02: MDP PEPTIDE 9 BIO SUN STICK PRO (version 1))

72220 002 04: Mdp Peptide 9 Bio Sun Stick Pro (version 2) (72220-002-04: MDP PEPTIDE 9 BIO SUN STICK PRO (version 2))


Advanced Ingredient Data


Raw Label Data

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