OBGE PORE-ZERO OIL CONTROL SUN STICK- homosalate, octocrylene, octisalate, avobenzone stick

Drug Labeling and Warnings

Drug Details [pdf]

KEEP OUT OF REACH OF CHILDREN

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

ACTIVE INGREDIENT

Avobenzone 2.8%

Homosalate 9.5%

Octisalate 4.5%

Octocrylene 5.0%

PURPOSE

Sunscreen

INDICATIONS & 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.

WARNINGS

For external use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor if rash occurs.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

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 of 15 or higher and other sun protection measures including: - Limit time in the sun, especially from 10 am to 2 pm. - Wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENT

Methyl Methacrylate Crosspolymer, Ethylhexyl Isononanoate, Synthetic Wax, Dimethicone/Vinyl Dimethicone Crosspolymer, Diethylhexyl Carbonate, Butyloctyl Salicylate, Diphenylsiloxy Phenyl Trimethicone, Isopropyl Palmitate, Dimethicone, Phenethyl Benzoate, Diisostearyl Malate, Dimethiconol, Trisiloxane, Phenyl Propyl Trimethicone, Synthetic Fluorphlogopite, Ethylhexyl Methoxycrylene, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Polyethylene, Ethylene/Propylene Copolymer, Camellia Japonica Seed Oil, Silica Dimethyl Silylate, Candelilla Wax Esters, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Copernicia Cerifera (Carnauba) Wax, Water, Dipropylene Glycol, Madecassoside, Zinc PCA, Butylene Glycol, Propanediol, Asiaticoside, Madecassic Acid, Asiatic Acid, Caprylic/Capric Triglyceride, Mentha Aquatica Extract, Mentha Viridis (Spearmint) Extract, Origanum Vulgare Leaf Extract, 1,2-Hexanediol, Pistacia Lentiscus (Mastic) Gum, Hydrogenated Lecithin, Melissa Officinalis Extract, Pentylene Glycol, Totarol, Phenethyl Alcohol, Camellia Sinensis Leaf Extract, Mentha Rotundifolia Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract, Oenothera Biennis (Evening Primrose) Flower Extract, Pinus Palustris Leaf Extract, Pueraria Lobata Root Extract, Ulmus Davidiana Root Extract, Ethylhexylglycerin

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OBGE PORE-ZERO OIL CONTROL SUN STICK 
homosalate, octocrylene, octisalate, avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87343-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.8 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
PHENETHYL BENZOATE (UNII: 0C143929GK)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
TRISILOXANE (UNII: 9G1ZW13R0G)
PHENYL PROPYL TRIMETHICONE (UNII: 6K97RP6G9H)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BIS-BEHENYL/ISOSTEARYL/PHYTOSTERYL DIMER DILINOLEYL DIMER DILINOLEATE (UNII: G27BTQ95MJ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
CARNAUBA WAX (UNII: R12CBM0EIZ)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
ZINC PIDOLATE (UNII: C32PQ86DH4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
ASIATICOSIDE (UNII: PKO39VY215)
MADECASSIC ACID (UNII: M7O1N24J82)
ASIATIC ACID (UNII: 9PA5A687X5)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MENTHA SPICATA WHOLE (UNII: O2H83I4PUN)
OREGANO (UNII: 0E5AT8T16U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TOTAROL (UNII: 67NH2854WW)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MENTHA X ROTUNDIFOLIA LEAF (UNII: K59TXG2L3U)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
OENOTHERA BIENNIS FLOWER (UNII: Y1YXJ1M6Z5)
PINUS PALUSTRIS LEAF (UNII: OT6R5143A1)
ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87343-002-02	1 in 1 CARTON	05/03/2026
1	NDC: 87343-002-01	18 g in 1 TUBE; 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	05/03/2026

Labeler - Adapt Inc. (694865012)

Registrant - Adapt Inc. (694865012)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(87343-002)