SPF33 MINERAL FACIAL CARIPOSA- zinc oxide lotion

SPF33 Mineral Facial by

Drug Labeling and Warnings

SPF33 Mineral Facial by is a Otc medication manufactured, distributed, or labeled by Talent Brands Company LLC, Bridgeview Investments LLC, Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                               Purpose

Zinc Oxide 20%                                   Sunscreen

PURPOSE

Uses

helps prevent sunburn If used as directed with other sun protection measures ( see Oirections),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 waterto remove.

Stop use and ask a doctor if

rash or initation develops and lasts

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

Directions:

apply liberally 15 minutes before sun exposure and as needed. Reapply:

after 40 minutes of sweeming or sweating immidiately after towel drying at least every 2 hours.  Sun Protection Measures. Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly usea sunscreen wrtha Broad Spectrum SPF value of15 or higher and other suncrin protection measures including:
limrt time in the sun, especial from 10a.m. -2 p.rn.wear long-sleeve shorts , pants, hats and sunglasses

• children under 6 months of age: ask a doctor

Other information

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

Inactive ingredients

Benzyl Alcohol, Butyloctyl Salicylate, Caprylic/Capric
Triglyceride, Citric Acid, Coco-Caprylate, Dehydroacetic Acid, Glycerin, Glyceryl Stearate,
Niacinamide, Panthenol, Polyhydroxystearic Acid, Saccharide Isomerate, Sodium
Phytate, Sodium Stearoyl Glutamate, Sucrose Palmitate, Sucrose Tristearate,
Tocopheryl Acetate, Xanthan Gum, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF33 MINERAL FACIAL   CARIPOSA
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84267-004
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO-CAPRYLATE (UNII: 4828G836N6)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PHYTATE SODIUM (UNII: 88496G1ERL)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
SUCROSE TRISTEARATE (UNII: 71I93STU5M)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84267-004-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/18/2024

Labeler - Talent Brands Company LLC (061158156)

Registrant - Bridgeview Investments LLC (035014854)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(84267-004)