337c3528-5739-6b4a-e063-6294a90a3cb4

SPL v2
SPL
SPL Set ID 337c3528-5739-6b4a-e063-6294a90a3cb4
Route
topical
Published
Effective Date 2025-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
ethylhexyl salicylate (4.5 g) octocrylene (5 g) homosalate (6 g) zinc oxide (10.3 g)
Inactive Ingredients
lauroyl lysine hyaluronic acid caprylic/capric triglyceride panax ginseng whole resveratrol propanediol ethylhexylglycerin dimethylsilanol hyaluronate potassium cetyl phosphate butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) panax ginseng fruit panax ginseng leaf sodium hyaluronate silybum marianum whole pentylene glycol sodium acrylates crosspolymer-2 triethoxycaprylylsilane panax ginseng root peg-9 diglycidyl ether/sodium hyaluronate crosspolymer maltodextrin glycyrrhiza uralensis root cetearyl olivate 1,2-hexanediol sodium polyacryloyldimethyl taurate nelumbo nucifera flower cimicifuga racemosa root sodium acetylated hyaluronate hydroxyacetophenone panthenol neopentyl glycol diethylhexanoate trisodium ethylenediamine disuccinate acetyl glucosamine polyacrylate crosspolymer-6 sorbitan olivate schisandra sphenanthera fruit glyceryl stearate butylene glycol caprylyl glycol glycerin water coco-caprylate/caprate tromethamine dipropylene glycol stearic acid cetearyl alcohol polyhydroxystearic acid (2300 mw)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-04-23

Purpose

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.

Description

Active Ingredients Purpose Homosalate 6.0% Sunscreen Octisalate 4.5% Sunscreen Octocrylene 5.0% Sunscreen Zinc Oxide 10.3% Sunscreen


Medication Information

Warnings and Precautions

For external use only.

Active Ingredient

Active Ingredients Purpose

Homosalate 6.0% Sunscreen

Octisalate 4.5% Sunscreen

Octocrylene 5.0% Sunscreen

Zinc Oxide 10.3% Sunscreen

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.

Purpose

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

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hour. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. For children under 6 months of age, consult a doctor.

Description

Active Ingredients Purpose Homosalate 6.0% Sunscreen Octisalate 4.5% Sunscreen Octocrylene 5.0% Sunscreen Zinc Oxide 10.3% Sunscreen

Section 44425-7

Protect this product from excessive heat, freezing and direct sunlight. Store at room temperature.

May cause staining on some fabrics.

Section 50565-1

If swallowed, seek medical assistance or contact a Poison Control Center immediately.

Section 50566-9

rash occurs.

Section 50567-7

Avoid contact with eyes. Rinse thoroughly with water if contact occurs.

Section 50570-1

on damaged or broken skin

Section 51727-6

Water, Caprylic/Capric Triglyceride, Propanediol, Glycerin, Coco-Caprylate/Caprate, Cetearyl Olivate, 1,2-Hexanediol, Pentylene Glycol, Potassium Cetyl Phosphate, Sorbitan Olivate, Cetearyl Alcohol, Glyceryl Stearate, Lauroyl Lysine, Hydroxyacetophenone, Sodium Acrylates Crosspolymer-2, Triethoxycaprylylsilane, Sodium Polyacryloyldimethyl Taurate, Stearic Acid, Panthenol, Tromethamine, Neopentyl Glycol Diethylhexanoate, Trisodium Ethylenediamine Disuccinate, Butylene Glycol, Polyacrylate Crosspolymer-6, Panax Ginseng Berry Extract, Panax Ginseng Extract, Panax Ginseng Leaf/Stem Extract, Panax Ginseng Root Extract, Acetyl Glucosamine, Sodium Hyaluronate, Ethylhexylglycerin, Maltodextrin, Schisandra Sphenanthera Fruit Extract, Caprylyl Glycol, Glycyrrhiza Uralensis (Licorice) Root Extract, Dipropylene Glycol, Nelumbo Nucifera Flower Extract, Cimicifuga Racemosa Root Extract, Resveratrol, Silybum Marianum Extract, Dimethylsilanol Hyaluronate, Hyaluronic Acid, Sodium Acetylated Hyaluronate, BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW), PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER

Section 51945-4

LAPCOS

SPF 50

BROAD SPECTRUM

DAILY SUNSCREEN HYBRID FORMULA

with Ginseng Extract

50 g / 1.76 OZ.


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Active Ingredients Purpose

Homosalate 6.0% Sunscreen

Octisalate 4.5% Sunscreen

Octocrylene 5.0% Sunscreen

Zinc Oxide 10.3% Sunscreen

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.

Purpose

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)

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hour. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. For children under 6 months of age, consult a doctor.

Section 44425-7 (44425-7)

Protect this product from excessive heat, freezing and direct sunlight. Store at room temperature.

May cause staining on some fabrics.

Section 50565-1 (50565-1)

If swallowed, seek medical assistance or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

rash occurs.

Section 50567-7 (50567-7)

Avoid contact with eyes. Rinse thoroughly with water if contact occurs.

Section 50570-1 (50570-1)

on damaged or broken skin

Section 51727-6 (51727-6)

Water, Caprylic/Capric Triglyceride, Propanediol, Glycerin, Coco-Caprylate/Caprate, Cetearyl Olivate, 1,2-Hexanediol, Pentylene Glycol, Potassium Cetyl Phosphate, Sorbitan Olivate, Cetearyl Alcohol, Glyceryl Stearate, Lauroyl Lysine, Hydroxyacetophenone, Sodium Acrylates Crosspolymer-2, Triethoxycaprylylsilane, Sodium Polyacryloyldimethyl Taurate, Stearic Acid, Panthenol, Tromethamine, Neopentyl Glycol Diethylhexanoate, Trisodium Ethylenediamine Disuccinate, Butylene Glycol, Polyacrylate Crosspolymer-6, Panax Ginseng Berry Extract, Panax Ginseng Extract, Panax Ginseng Leaf/Stem Extract, Panax Ginseng Root Extract, Acetyl Glucosamine, Sodium Hyaluronate, Ethylhexylglycerin, Maltodextrin, Schisandra Sphenanthera Fruit Extract, Caprylyl Glycol, Glycyrrhiza Uralensis (Licorice) Root Extract, Dipropylene Glycol, Nelumbo Nucifera Flower Extract, Cimicifuga Racemosa Root Extract, Resveratrol, Silybum Marianum Extract, Dimethylsilanol Hyaluronate, Hyaluronic Acid, Sodium Acetylated Hyaluronate, BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW), PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER

Section 51945-4 (51945-4)

LAPCOS

SPF 50

BROAD SPECTRUM

DAILY SUNSCREEN HYBRID FORMULA

with Ginseng Extract

50 g / 1.76 OZ.


Advanced Ingredient Data


Raw Label Data

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