SPF 30 MINERAL SUNSCREEN CARIPOSA- titanium dioxide, zinc oxide cream

SPF 30 Mineral Sunscreen by

Drug Labeling and Warnings

SPF 30 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Talent Brands Company LLC, Bridgeview Investments LLC, DermaCare researcg Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                                Purpose

Titanium Dioxide  4.5%                         Sunscreen

Zinc Oxide            4%                            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 80 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

ALOE
ALUMINUM OXIDE
ALUMINUM STARCH OCTENYLSUCCINATE
ALKYL (C12-15) BENZOATE
CAMELLIA SINENSIS FLOWER
CETYL PEG/PPG-10/1 DIMETHICONE
CUCUMBER FRUIT OIL
DIMETHICONE
EDETATE DISODIUM
ETHYLHEXYL PALMITATE
ETHYLHEXYLGLYCERIN
GLYCERIN
HYDROGEN DIMETHICONE
MENTHA PIPERITA
Oryza Sativa Brain Water
PHENOXYETHANOL
PROPANEDIOL
POMEGRANATE JUICE
SALVIA ROSMARINUS FLOWER
SILICON DIOXIDE
SODIUM CHLORIDE
SORBITAN OLIVATE
STYRENE/ACRYLAMIDE COPOLYMER
WINE GRAPE JUICE
WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF 30 MINERAL SUNSCREEN   CARIPOSA
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84267-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
RICE BRAN, DEFATTED (UNII: H6597RO5A2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
POMEGRANATE JUICE (UNII: 99S671U9KB)
SALVIA ROSMARINUS FLOWER (UNII: NR1A27F29O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
WINE GRAPE JUICE (UNII: JHQ6158A7R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84267-001-02	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/29/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/29/2023

Labeler - Talent Brands Company LLC (061158156)

Registrant - Bridgeview Investments LLC (035014854)

Establishment
Name	Address	ID/FEI	Business Operations
DermaCare researcg Labs, LLC		116817470	manufacture(84267-001)