3LAB WW DAY SPF40 BROAD SPECTRUM- homosalate, octisalate, avobenzone, octocrylene cream

3LAB WW DAY SPF40 BROAD SPECTRUM by

Drug Labeling and Warnings

3LAB WW DAY SPF40 BROAD SPECTRUM by is a Otc medication manufactured, distributed, or labeled by 3LAB, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Homosalate 10%

Octisalate 5%

Avobenzone 3.0%

Octocrylene 2.6%

PURPOSE

Purpose

Sunscreen

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

For external use only.

Do not useon damaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove

Stop use and ask a doctorif rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

Bottle Packaging Label

OTHER INFORMATION

Other information

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

3LAB WW DAY SPF40 BROAD SPECTRUM 
homosalate, octisalate, avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76159-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SQUALANE (UNII: GW89575KF9)
OLIVE OIL (UNII: 6UYK2W1W1E)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)
ORANGE OIL (UNII: AKN3KSD11B)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LAVANDIN OIL (UNII: 9RES347CKG)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SHEA BUTTER (UNII: K49155WL9Y)
CERAMIDE 3 (UNII: 4370DF050B)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ERYTHROPOIETIN (UNII: 64FS3BFH5W)
GOLD (UNII: 79Y1949PYO)
WINE GRAPE (UNII: 3GOV20705G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)
DIACETYL BOLDINE (UNII: 37727Z7M0I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SESAME OIL (UNII: QX10HYY4QV)
ISODODECANE (UNII: A8289P68Y2)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
AZADIRACHTA INDICA BARK (UNII: G580B439YI)
XANTHAN GUM (UNII: TTV12P4NEE)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
ISOMALT (UNII: S870P55O2W)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76159-205-00	1 in 1 CARTON	05/27/2016
1		50 mg in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/27/2016

Labeler - 3LAB, INC (162333277)