SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREEN- zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 15.4%

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

Warnings
For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

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

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if swimming
or sweating Chlldren under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients
Water, Octyldodecyl Myristate, Glycerin, Polyglyceryl-3 Diisostearate, Triheptanoin,
Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyhydroxystearate, C13-16 Isoalkane,
Polyglyceryl-6 Polyricinoleate, Cetearyl Olivate, Tocopherol, Ethyl Ferulate,
Triethoxycaprylylsilane, Polyglycerin-6, Sorbitan Olivate, Stearalkonium Hectorite,
Propylene Carbonate, Silica, Cera Alba (Beeswax), Portulaca Oleracea Extract,
Butylene Glycol, Withanla Somnifera Root Extract, Theobroma Cacao (Cocoa) Seed
Butter, Caesalpinia Spinosa Fruit Extract, Propanediol, Tremella Fuciformis
Sporocarp Extract, Betaine, Pongamia Glabra Seed Oil, Glycine Soja (Soybean) Oil,
Oryza Sativa (Rice] Extract, Oryza Sativa (Rice) Germ Extract, Camellia Sinensis Leaf
Extract, Sodium Chloride, Tetrasodium Glutamate Diacetate, Fragrance (Natural)

STORAGE AND HANDLING

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

Store at room temperature

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87608-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	154 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
POLYGLYCERIN-6 (UNII: M51422LRAM)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYL FERULATE (UNII: 5B8915UELW)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PONGAMIA GLABRA SEED OIL (UNII: 62160PU6FJ)
BETAINE (UNII: 3SCV180C9W)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SORBITAN OLIVATE (UNII: MDL271E3GR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87608-002-02	1 in 1 BOX	04/27/2026
1	NDC: 87608-002-01	1 mL in 1 CONTAINER; 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	04/27/2026

Labeler - Zouck LLC (140821818)

Establishment
Name	Address	ID/FEI	Business Operations
Milbar Laboratories, Inc.		195556790	manufacture(87608-002)