MINERAL SUNSCREEN SPF 50 BROAD SPECTRUM- zinc oxide lotion

Mineral Sunscreen SPF 50 Broad Spectrum by

Drug Labeling and Warnings

Mineral Sunscreen SPF 50 Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by Figure 1 Beauty, Inc., ENGLEWOOD LAB, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT
ZINC OXIDE 18.76% ….

PURPOSE

PURPOSE
..... SUNSCREEN

INDICATIONS & USAGE

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 USE ON DAMAGED OR BROKEN SKIN
WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
STOP USE AND ASK A DOCTOR IF RASH OCCURS

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION

DIRECTIONS

• SHAKE WELL BEFORE USE.
• APPLY LIBERALLY AND EVENLY 15 MINUTES BEFORE SUN EXPOSURE.
• REAPPLY AT LEAST EVERY 2 HOURS
• APPLY TO ALL SKIN EXPOSED TO THE SUN.
• CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

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 10 A.M. - 2 P.M., WEAR LONG SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES

STORAGE AND HANDLING

OTHER INFORMATION

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
• SUITABLE FOR: ALL SKIN TYPES.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS
Water (Aqua), Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Squalane, Butyloctyl Salicylate,
Polymethylsilsesquioxane, Copernicia Cerifera (Carnauba) Wax, Coconut Alkanes, Dimethicone,
Propanediol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Caprylyl
Methicone, Argania Spinosa Kernel Oil, Ethylhexyl Methoxycrylene, Tocopheryl Acetate, Glycerin,
Isododecane, Limnanthes Alba (Meadowfoam) Seed Oil, Plankton Extract, Micrococcus Lysate,
Hydrolyzed Hyaluronic Acid, Pongamia Pinnata Seed Extract, Oryza Sativa (Rice) Bran Wax, Lecithin,
Tocopherol, Sodium Chloride, Magnesium Chloride, Coco-Caprylate/Caprate, Xanthan Gum, Stearalkonium
Hectorite, Glyceryl Caprylate, Bisabolol, Polysilicone-11, Polyhydroxystearic Acid, Lauryl
Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxycaprylylsilane, Propylene Carbonate,
Caprylhydroxamic Acid, Hydroxyacetophenone, Phenethyl Alcohol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN SPF 50 BROAD SPECTRUM 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84100-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	187.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
TOCOPHEROL (UNII: R0ZB2556P8)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ISODODECANE (UNII: A8289P68Y2)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCONUT ALKANES (UNII: 1E5KJY107T)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
XANTHAN GUM (UNII: TTV12P4NEE)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84100-0001-2	1 in 1 CARTON	08/26/2024
1	NDC: 84100-0001-1	50 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	08/26/2024

Labeler - Figure 1 Beauty, Inc. (118220442)

Establishment
Name	Address	ID/FEI	Business Operations
ENGLEWOOD LAB, INC.		172198223	manufacture(84100-0001)