PURE SOL SPF15 LIP GLOSS NUDIE ROSE- zinc oxide liquid

PURE SOL SPF15 Lip Gloss Nudie rose by

Drug Labeling and Warnings

PURE SOL SPF15 Lip Gloss Nudie rose by is a Otc medication manufactured, distributed, or labeled by Brand 2022b LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 7.2%

PURPOSE

Helps prevent sunburn.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

INDICATIONS & USAGE

■Apply liberally and evenly 15 minutes before sun exposure.

■Reapply at least every two 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 AM – 2 PM

wear long sleeve shirts, pants, hats, and sunglasses

DOSAGE & ADMINISTRATION

■Apply liberally and evenly 15 minutes before sun exposure.

■Reapply at least every two hours.

■Sun Protection Measures: Spending time in the sun increases

INACTIVE INGREDIENT

POLYISOBUTENE
TRIDECYL TRIMELLITATE
PHENYL METHICONE
C12-15 ALKYL BENZOATE
CETYL DIMETHICONE
ETHYLHEXYL PALMITATE
SILICA
TRIETHOXYCAPRYLYLSILANE
CETYL PEG/PPG-10/1 DIMETHICONE
PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE
CERA MICROCRISTALLINA
PARAFFIN
STEARYL DIMETHICONE
TRIBEHENIN
CERA MICROCRISTALLINA
FLAVOR
SILICA DIMETHYL SILYLATE
CI 77019
CI 77491
DISTEARDIMONIUM HECTORITE
WATER
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
SORBITAN ISOSTEARATE
TOCOPHERYL ACETATE
CI 45370
BHT
CI 45380

WARNINGS

For external use only

When using this product keep out of eyes.

Rinse with water to remove - do not use on broken skin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURE SOL SPF15 LIP GLOSS NUDIE ROSE 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84090-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CI 45370 (UNII: 7MF02AWG95)
STEARYL TRISILOXANE (UNII: 796MG354ZZ)
BHT (UNII: 1P9D0Z171K)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PARAFFIN (UNII: I9O0E3H2ZE)
HYDROGENATED POLYISOBUTENE 8 (UNII: 7YR4ZFS62E)
MICA (UNII: V8A1AW0880)
CI 45380 (UNII: TDQ283MPCW)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PHENYL METHICONE (500 CST) (UNII: 5T0F958X3Z)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER (UNII: AE7QA6TW0Q)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SILICA (UNII: ETJ7Z6XBU4)
CI 77491 (UNII: 1K09F3G675)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
FLAVOR SPICE MINT N&A110589 (UNII: KG6KU384XW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84090-007-01	4 mL in 1 TUBE; Type 0: Not a Combination Product	10/04/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/04/2025

Labeler - Brand 2022b LLC (119190557)

Registrant - Brand 2022b LLC (119190557)