CHEM-FREE ACTIVE DEFENSE SPF 30- zinc oxide cream

Chem-Free Active Defense SPF 30 by

Drug Labeling and Warnings

Chem-Free Active Defense SPF 30 by is a Otc medication manufactured, distributed, or labeled by Van Laere LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 17.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Retains SPF after 80 minutes of activity in the water or perspiring

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

Stop use and ask a doctor if rash occurs

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

Directions

Apply generously 15 minutes before sun exposure.

Reapply:

• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 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 10am–2pm
  • wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor

Other information

Protect this product from excessive heat and direct sun. Report a serious adverse event reaction to: van laere llc. 119 Fifth Avenue, New York, NY 10003

Inactive Ingredients

Water (Aqua), Isononyl Isononanoate, Caprylic/Capric Triglyceride, Dimethicone, Hexylene Glycol, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Argania Spinosa Kernel Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copoly Polyglyceryl-4 Isostearate, Tocopheryl Acetate, Polyhydroxystearic Acid, Squalane, Polyglyceryl-3 -Poyricinoleate, Phenoxyethanol, Lecithin, Sodium Chloride, Isostearic Acid, Hexyl Laurate Ethylhexylglycerin, Bisabolol, Caprylyl Glycol, Polysorbate 60, Chlorphenesin, Disodium EDTA

SPL UNCLASSIFIED SECTION

Distributed by van laere llc, New York, NY10003, USA

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

N
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NEW YORK
DERMATOLOGY
GROUP
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Chem-Free Active Defense SPF30

INGREDIENTS AND APPEARANCE

CHEM-FREE ACTIVE DEFENSE SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71994-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	175 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Isononyl Isononanoate (UNII: S4V5BS6GCX)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Dimethicone (UNII: 92RU3N3Y1O)
Hexylene Glycol (UNII: KEH0A3F75J)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
ARGAN OIL (UNII: 4V59G5UW9X)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
Squalane (UNII: GW89575KF9)
Phenoxyethanol (UNII: HIE492ZZ3T)
Isostearic Acid (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
Sodium Chloride (UNII: 451W47IQ8X)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Ethylhexylglycerin (UNII: 147D247K3P)
LEVOMENOL (UNII: 24WE03BX2T)
Caprylyl Glycol (UNII: 00YIU5438U)
Polysorbate 60 (UNII: CAL22UVI4M)
Chlorphenesin (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Farnesol (UNII: EB41QIU6JL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71994-007-10	1 in 1 CARTON	05/01/2018
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71994-007-40	1 in 1 CARTON	05/01/2018
2		120 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2018

Labeler - Van Laere LLC (081010441)