SPF50 SUNSCREEN CARIPOSA- zinc oxide stick

SPF50 Sunscreen by

Drug Labeling and Warnings

SPF50 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                                    ingredient

Zinc Oxide 21.6% ................Sunscreen

Purpose

Sunscreen

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 For external use only

Do not use on

damaged or broken skin

When using this product

keep out of eyes. Rinse eyes with water to remove

Stop use and ask a doctor if

rash or irritation develops and lasts

Keep out of the reach of children

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

Directions

apply liberally 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 10 a.m.-2 p.m.  wear long-sleeved shirts, 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

Adipic Acid/Diglycol Crosspolymer, C12-15 Alkyl Benzoate,
Caprylyl Glycol, Isopropyl Myristate, Neopentyl Glycol
Diethylhexanoate, Neopentyl Glycol Diisostearate,
Octyldodecyl Neopentanoate, Ozokerite, Paraffin, Silica,
Synthetic Wax, Tocopheryl Acetate, Triethoxycaprylylsilane

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF50 SUNSCREEN   CARIPOSA
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84267-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	21.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CERESIN (UNII: Q1LS2UJO3A)
PARAFFIN (UNII: I9O0E3H2ZE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84267-002-01	43 g in 1 CONTAINER; Type 0: Not a Combination Product	10/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/16/2023

Labeler - Talent Brands Company LLC (061158156)

Registrant - Bridgeview Investments LLC (035014854)

Establishment
Name	Address	ID/FEI	Business Operations
DermaCare researcg Labs, LLC		116817470	manufacture(84267-002)