ZINC OXIDE 20.00%- spf 50 mineral lotion

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient                    Purpose

Zinc Oxide 20% ......................Sunscreen

PURPOSE

Uses

Helps prevent sunburn

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.

Ingredients

1,2-Hexancdiol
Aloc Barbadcnsis Lcaf Extract
Aloe Barbadensis Leaf Juice
Ascorhvl Palmitate
Butylcnc Glycol
Butyloctyl Salicylate
ButyrosDerrnum Parkii (Shea) Butler
Caprylic/Capric Triglivceride
Cetearvl Olivate
Daucus Carota Sativa (Carrot) Rioot Extract
Dicaprylyl Carbonatc
Dimethicone
Ethylhexyl Methoxycrvlene
.bthylhexylglvccrin
Iragrancc
Helianthus Amuus (Sunllorver) Seed Oil
Hydrogcnatecl Castor Oil
Isoplorryl N,lyristate
Magncsium Sulfate
Mansifera lndica (Mar.rgo) Seed Butter
Mineral Oil
Niacinamiclc
Phenoxyethanol
Phospholipids
Polvslvceiryl-3 .Polyr icinoleate
Polyhydroxystearic Acid
Rctinyl Palmitate
Ilubus ldaeus (Red Raspbern) Seccl Oil
Sodiunr llyaluronate
Sorbitan Olcate
Sorbitan Olivate
Synthctic Bccsu,ax
Tocopheryl Acetate
VP/Hexadecene Copolymer
Water
Xanthan Gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC OXIDE 20.00% 
spf 50 mineral lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85033-001
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
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALOE (UNII: V5VD430YW9)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
DAUCUS CAROTA SATIVA (CARROT) JUICE (UNII: QXF936IX43)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FRAGRANCE ESC 10-740 (UNII: QH92QT9LWR)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM SULFATE (UNII: DE08037SAB)
MANGO SEED OIL (UNII: K8LOR30915)
MINERAL OIL (UNII: T5L8T28FGP)
NIACINAMIDE (UNII: 25X51I8RD4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BOVINE LUNG PHOSPHOLIPIDS ADULT (UNII: EA3D6UW549)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
RUBUS IDAEUS (RASPBERRY) SEED OIL (UNII: 9S8867952A)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SORBITAN OLEATE (UNII: 06XEA2VD56)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85033-001-04	177 mL in 1 TUBE; Type 0: Not a Combination Product	10/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/10/2025

Labeler - Coconut Caliente Costa Rica LLC (119375163)

Registrant - Inspec Solutions (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions		081030372	manufacture(85033-001)