ENVIRONMENTAL DEFENSE- zinc oxide cream

Environmental Defense by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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, or nuts. 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),*Jojoba Oil, *Sunflower Oil, **Candelilla wax, *Calophyllum Inophyllum (Tamanu) Oil, **Argania spinosa (Argan) Oil, Silica,Theobroma Grandiflorum (Cupuacu) Butter, *Butyrospermum parkii (Shea) Butter, *Mauritia Flexuosa (Buriti) Oil, Emu Oil,*Rubus Idaeus (Raspberry) Seed Oil, *Beeswax, Propolis, Tocopherol, *Fragrance, Mica, Plankton Extract, *Rosemary Extract, Iron Oxides.

*Organic **Wildcrafted

SPL UNCLASSIFIED SECTION

Other information Shake well before use. Warm as needed

QUESTIONS

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

Manufactured in the USA for
AVASOL
1187 Coast Village # 611
Santa Barbara, CA 93108

Principal Display Panel - 2.5oz Bottle Label

avasol®

natural mineral
sunscreen

30 SPF

2.5 FL OZ (75 ml)

INGREDIENTS AND APPEARANCE

ENVIRONMENTAL DEFENSE 
zinc oxide cream

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

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

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
JOJOBA OIL (UNII: 724GKU717M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CANDELILLA WAX (UNII: WL0328HX19)
TAMANU OIL (UNII: JT3LVK84A1)
ARGAN OIL (UNII: 4V59G5UW9X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V)
SHEANUT (UNII: 84H6HBP32L)
MAURITIA FLEXUOSA WHOLE (UNII: 83ULF8L5FI)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
YELLOW WAX (UNII: 2ZA36H0S2V)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
MANUKA OIL (UNII: M6QU9ZUH2X)
ROSEMARY (UNII: IJ67X351P9)
CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58518-010-01	75 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/18/2013

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

Labeler - Avasol LLC (078822898)

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