3LAB WW DAY SPF40 BROAD SPECTRUM

Manufacturer
3LAB, INC
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:49:01

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Homosalate 10% Octisalate 5% Avobenzone 3.0% Octocrylene 2.6%

OTC - PURPOSE SECTION

Purpose Sunscreen

Uses

USES

Uses 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

Warnings

WARNINGS

Warnings For external use only.

Directions And Dosage

DIRECTIONS

Directions Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months: Ask a doctor Apply to all skin exposed to the sun

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive Ingredients Isododecane, Dimethicone/ Bis-Isobutyl PPG-20 Crosspolymer, Ethylhexyl Palmitate, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Water, Glycerin, PEG-12 Dimethicone/PPG-20 Crosspolymer, Silica, Melia Azadirachta Extract, Sesamum Indicum (Sesame) Seed Oil, Moringa Oleifera Seed Oil, Olea Europaea (Olive) Fruit Oil, Oligopeptide-4, Oligopeptide-5, sh-Polypeptide-7, Acetyl Heptapeptide-9, Isomalt, Vitis Vinifera (Grape) Fruit Cell Extract, Malus Domestica Fruit Cell Culture Extract, Lecithin, Xanthan Gum, Hydrolyzed Pea Protein, Squalane, Phytosterols, Ceramide NP, Butyrospermum Parkii (Shea) Butter, Tocopherol, Tocopheryl Acetate, Diacetyl Boldine, Phenoxyethanol, Dimethyl Isosorbide, Sodium Phosphate, Disodium EDTA, Colloidal Gold, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Lavandula Hybrida Oil

Outer Packaging Label

Label Images#

3LAB_WW DAY SPF40_Bottle
3LAB_WW DAY SPF40_Bottle
3LAB_WW DAY SPF40_UnitBox
3LAB_WW DAY SPF40_UnitBox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76159-205-003LAB WW DAY SPF40 BROAD SPECTRUM50 mg in 1 BOTTLECREAM501
76159-205-003LAB WW DAY SPF40 BROAD SPECTRUM1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76159-2053LAB WW DAY SPF40 BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]1Current NDC, 2 package rows20241228_2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e.zip

DailyMed Biologic / Drug Substance Indexing#

Product, Base substance, Indexed substance code table
ProductBase substanceIndexed substance codeIndexed substanceApplicationIndexing SPLSPL versionEffective
RETACRITERYTHROPOIETIN64FS3BFH5W-EPBX-01epoetin alfa-epbxBLA1255458ba23d58-e94d-494e-84e7-b775aad9cfdf12018-05-15

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76159-20576159-205-00

Ingredients#

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Homosalate 10% Octisalate 5% Avobenzone 3.0% Octocrylene 2.6%

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose Sunscreen

USES

INDICATIONS & USAGE SECTION

Uses 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

WARNINGS

WARNINGS SECTION

Warnings For external use only.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months: Ask a doctor Apply to all skin exposed to the sun

Bottle Packaging Label

COMPONENTS

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive Ingredients Isododecane, Dimethicone/ Bis-Isobutyl PPG-20 Crosspolymer, Ethylhexyl Palmitate, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Water, Glycerin, PEG-12 Dimethicone/PPG-20 Crosspolymer, Silica, Melia Azadirachta Extract, Sesamum Indicum (Sesame) Seed Oil, Moringa Oleifera Seed Oil, Olea Europaea (Olive) Fruit Oil, Oligopeptide-4, Oligopeptide-5, sh-Polypeptide-7, Acetyl Heptapeptide-9, Isomalt, Vitis Vinifera (Grape) Fruit Cell Extract, Malus Domestica Fruit Cell Culture Extract, Lecithin, Xanthan Gum, Hydrolyzed Pea Protein, Squalane, Phytosterols, Ceramide NP, Butyrospermum Parkii (Shea) Butter, Tocopherol, Tocopheryl Acetate, Diacetyl Boldine, Phenoxyethanol, Dimethyl Isosorbide, Sodium Phosphate, Disodium EDTA, Colloidal Gold, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Lavandula Hybrida Oil

Outer Packaging Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML