PRO FORMULA- zinc oxide, titanium dioxide stick

Pro Formula by

Drug Labeling and Warnings

Pro Formula by is a Otc medication manufactured, distributed, or labeled by Avasol LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide (non-nano, Uncoated) 24.5%

Titanium Dioxide (non-nano, Uncoated) 6%

Purpose

Sunscreen

Sunscreen

Uses

• helps prevent sunburn

Warnings

• For external use only.
• Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation occurs.

Do not use if allergic to ingredients, or nuts. Test small area first.

Keep out of reach of children. If swallowed, get medical help right away.

Directions

• apply liberally before sun
• reapply: after 80 min. of swimming or sweating, immediately after towel drying, or as needed
• children under 6 months: Ask a doctor.

Inactive ingredients

*Caprylic/Capric Triglyceride (Coconut), *Cocos Nucifera (Coconut) Oil,*Helianthus annuus (Sunflower) Oil, **Euphorbia cerifera (Candelilla) wax, *Calophyllum Inophyllum (Tamanu)Oil,*Beeswax,**Theobroma Grandiflorum (Cupuacu) Seed Butter, Mica, Tocopherol (Vitamin E),*Aloe Vera Leaf, Iron oxides, *Propolis, *Rosmarinus Officinalis (Rosemary) Leaf Extract, **Leptospermum scoparium (Manuka) Oil,*Cinnamomum Zeylanicum(Cinnamon) Bark Oil.

*Organic **Wildcrafted

Other information

• protect package from moisture & extreme heat.

Questions?

visit www.avasol.com

Principal Display Panel - 28 g Tube Label

avasol®

mineral sunscreen
PRO 50+SPF

Net Wt 1 oz (28 g)

Pro-Grade Skin Barrier

Water-resistant (80 min.)

Broad Spectrum (UVA/UVB)

Safer for People & the Ocean

USDA Certified 100% Biobased

INGREDIENTS AND APPEARANCE

PRO FORMULA 
zinc oxide, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58518-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
TAMANU OIL (UNII: JT3LVK84A1)
CANDELILLA WAX (UNII: WL0328HX19)
THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
FERROUS OXIDE (UNII: G7036X8B5H)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MANUKA OIL (UNII: M6QU9ZUH2X)
ROSEMARY (UNII: IJ67X351P9)
CINNAMON BARK OIL (UNII: XE54U569EC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58518-030-03	28 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2023
2	NDC: 58518-030-04	224 g in 1 POUCH; Type 0: Not a Combination Product	05/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2023

Labeler - Avasol LLC (078822898)

Establishment
Name	Address	ID/FEI	Business Operations
Avasol LLC		078822898	MANUFACTURE(58518-030)