ZINC OXIDE 20%- sunscreen spf 50 lotion

Zinc Oxide 20% by

Drug Labeling and Warnings

Zinc Oxide 20% by is a Otc medication manufactured, distributed, or labeled by The Soleil Group, LLC, Inspec Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                                                        Purpose Zinc Oxide 20% .......................................................Sunscreen

PURPOSE

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.

Directions

Apply evenly to face and neck 15 minutes before sun
exposure reapply: After 80 minutes of swimming or sweating .
Immediately after towel drying . At least every 2 hours 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
10a.m.– 2p.m. . Wear long-sleeve shirts, pants, hats, and sunglasses.
. Children under 6 months: Ask a doctor.

Warnings For external use only.

Do not useon damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor ifrash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away

Inactive ingredients

Aloe Barbadensis Leaf Juice,
Aluminum Starch Octenylsuccinate,
Bisabolol,
Caprylic/Capric Triglyceride,
Capryloyl Glycerin/Sebacic Acid Copolymer,
Caprylyl Carbonate,
Diheptyl Succinate,
Ethylhexylglycerin,
Galactoarabinan,
Glycerin,
Glyceryl Stearate SE,
Helianthus Annuus (Sunflower) Seed Oil,
Jojoba Esters,
Magnesium Sulfate,
Mica,
Niacinamide,
Octyldodecanol,
Phenoxyethanol,
Polyglyceryl-2 Distearate,
Polyhydroxystearic Acid,
Porphyra Umbilicalis Extract,
Sodium Hyaluronate,
Squalane Oil,
Tetrahexyldecyl Ascorbate,
Tocopheryl Acetate,
Triethoxycaprylylsilane,
Trihydroxystearin,
Tripeptide-5,
VP/Hexadecene Copolymer,
Water,
Iron Oxide Red (CI 77491),
Tin Oxide (CI 77861),
Titanium Dioxide (CI 77891)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC OXIDE 20% 
sunscreen spf 50 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69630-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GALACTOARABINAN (UNII: SL4SX1O487)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
MAGNESIUM SULFATE (UNII: DE08037SAB)
MICA (UNII: V8A1AW0880)
NIACINAMIDE (UNII: 25X51I8RD4)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-2 DISTEARATE (UNII: 1XAX7BOH4W)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SQUALANE (UNII: GW89575KF9)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
WATER (UNII: 059QF0KO0R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69630-004-01	1 in 1 CARTON	12/01/2025
1		16 mL 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	10/09/2025

Labeler - The Soleil Group, LLC (079694651)

Registrant - Inspec Solutions (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions		081030372	manufacture(69630-004)