PURE SOL SPF 30 LIP BALM CACOA BUTTER- zinc oxide stick

PURE SOL SPF 30 LIP BALM CACOA BUTTER by

Drug Labeling and Warnings

PURE SOL SPF 30 LIP BALM CACOA BUTTER 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 7.68%

PURPOSE

-Helps prevent and temporarily chafed,chapped, cracked, or windburned skin and/or lips.
-helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.

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

INDICATIONS & USAGE

Apply liberally 15 minutes before sun exposure
- Reapply Liberally as often as necessary.
- 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 broad spectrum SPF of 15 or higher and other sun protection measures

INACTIVE INGREDIENT

MINERAL OIL
ETHYLHEXYL PALMITATE
CERA
PARAFFIN
TRIETHOXYCAPRYLYLSILANE
MICROCRYSTALLINE WAX
SYNTHETIC WAX
TRIDECYL TRIMELLITATE
POLYISOBUTENE
CAPRYLIC/CAPRIC TRIGLYCERIDE
HYDROGENATED COCONUT OIL
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
DIISOSTEARYL MALATE
CANDELILLA CERA
THEOBROMA CACAO (COCOA) SEED BUTTER
TOCOPHERYL ACETATE
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL
WATER
HONEY EXTRACT
BUTYLENE GLYCOL
HYDROXYACETOPHENONE
CI 19140
CI 15985

DOSAGE & ADMINISTRATION

limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURE SOL SPF 30 LIP BALM CACOA BUTTER 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84090-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.68 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CANDELILLA CERA (UNII: WL0328HX19)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CI 15985 (UNII: H77VEI93A8)
PEGZEREPOETIN ALFA (UNII: LR3UXN0193)
PARAFFIN (UNII: I9O0E3H2ZE)
SYNTHETIC WAX (1900 MW) (UNII: 5M631N9V0S)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL (UNII: 66YXD4DKO9)
CI 19140 (UNII: I753WB2F1M)
MINERAL OIL (UNII: T5L8T28FGP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
HONEY (UNII: Y9H1V576FH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84090-005-01	5 g 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)