Active Ingredients

Zinc Oxide (Non-nano) 22.5%

Purpose

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.

Test small area first.

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

Directions

Apply liberally before sun
Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours, or as needed
Children under 6 months: Ask a doctor
May stain some fabrics.

Inactive ingredients

Caprylic/Capric Triglyceride (Coconut), *Simmondsia Chinensis (Jojoba) Seed Oil,*Helianthus annuus (Sun flower) Oil,*Cocos Nucifera (Coconut) Oil,*Calophyllum Inophyllum (Tamanu)Oil,*Argania spinosa (Argan) Oil, Silica, *Beeswax,*Theobroma Grandiflorum (Cupuacu) Seed Butter,*Butyrospermum parkii (Shea Butter),**Mauritia Flexuosa (Buriti) Fruit Oil, Rubus idaeus (Raspberry) Seed Oil, Tocopherol (Vitamin E), Mica, Iron oxides, *Vanilla Planifolia(Vanilla) Fruit Extract, Plankton Extract,*Propolis,*Rosmarinus Officinalis (Rosemary) Leaf Extract,**Leptospermum scoparium (Manuka)Oil, *Cinnamomum Zeylanicum (Cinnamon) Bark Oil, Love. *Organic **Wildcrafted

Other information

Shake well before use. Warm as needed.

Questions?

Call 888-805-1507or visit www.avasol.com

Principal Display Panel - 2 Fl Oz Bottle Label

avasol®

mineral sunscreen

30 SPF

2 FL OZ (59 mL)

Principal Display Panel - 2 Fl Oz Bottle Label

ENVIRONMENTAL DEFENSE
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58518-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	225 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
COCONUT OIL (UNII: Q9L0O73W7L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
JOJOBA OIL (UNII: 724GKU717M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TAMANU OIL (UNII: JT3LVK84A1)
ARGAN OIL (UNII: 4V59G5UW9X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
YELLOW WAX (UNII: 2ZA36H0S2V)
THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V)
SHEANUT (UNII: 84H6HBP32L)
MAURITIA FLEXUOSA WHOLE (UNII: 83ULF8L5FI)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
TOCOPHEROL (UNII: R0ZB2556P8)
VANILLA BEAN (UNII: Q74T35078H)
MICA (UNII: V8A1AW0880)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
FERROUS OXIDE (UNII: G7036X8B5H)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
MANUKA OIL (UNII: M6QU9ZUH2X)
ROSEMARY (UNII: IJ67X351P9)
CINNAMON BARK OIL (UNII: XE54U569EC)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58518-010-02	60 mL in 1 POUCH; Type 0: Not a Combination Product	11/29/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/18/2013

Labeler - Avasol LLC (078822898)

Name	Address	ID/FEI	Business Operations
Establishment
Avasol LLC		078822898	MANUFACTURE(58518-010)

Drug Facts