Label: CHEM-FREE ACTIVE DEFENSE SPF 30- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71994-007-10, 71994-007-40 - Packager: Van Laere LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 23, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
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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
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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
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
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INGREDIENTS AND APPEARANCE
CHEM-FREE ACTIVE DEFENSE SPF 30
zinc oxide creamProduct 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)
